> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-in-healthy-male-subjects-to-investigate-the-5cbf2ca9-365d-4fdb-b6ec-aa6dd12ddb84 > Record changed: 2026-10-13 # A Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System NCT05275010 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) Participants 151 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) Lead sponsor Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) Start date 2022-05-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) Number of sites 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) ## Title and summary **Summary** This is a randomized, open-label, 2-arm, parallel-group, single-dose, multi-center study in healthy male subjects to investigate the comparability of the pharmacokinetics of the fixed-dose combination of pertuzumab and trastuzumab administered subcutaneously using the proprietary on-body delivery system or a handheld syringe with hypodermic needle. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) **Short title** A Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) **Official title** A Randomized, Open-Label, 2-Arm, Parallel Group, Single Dose, Multi-Centre Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) ## Dates **Completion date** 2023-10-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) **First posted** 2022-03-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) **Registry last updated** 2024-09-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) **Primary completion date** 2023-05-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) **Start date** 2022-05-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) ## Size and sites **Actual participants** 151 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) **Participants** 151 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) **Number of sites** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) **Lead sponsor** Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) ## Identifiers **Registry ID** NCT05275010 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) **ClinicalTrials.gov ID** NCT05275010 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Basic science **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) ## Outcomes ### Primary outcomes 1. Area Under the Time-Concentration Curve From the Start of Dosing to 63 Days (AUC0-62) for Serum Pertuzumab Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63 For the analysis of AUC0-62days, participants in the Per Protocol Pharmacokinetics (PK) Analysis Population (PAP) with missing Day 63 PK pertuzumab concentration data or with a Day 63 PK sample time deviation outside a +/-120-hour window of planned sampling time were excluded. Participants were excluded from the PAP for the following reasons: 1\. The participant violates inclusion or exclusion criteria regarding body mass index (BMI), use of prohibited medications and concomitant subcutaneous, intravenous (IV), or any parenteral drugs, participation in an investigational drug or device study, current chronic daily treatment with corticosteroids, and receipt of IV antibiotics for infection. 2\. An SC injection site other than thigh is used; 3\. Any participant whose injection is not successfully performed. 2. Area Under the Time-Concentration Curve From the Start of Dosing to 63 Days (AUC0-62) for Serum Trastuzumab Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63 For the analysis of AUC0-62days, participants in the Per Protocol Pharmacokinetics (PK) Analysis Population (PAP) with missing Day 63 PK trastuzumab concentration data or with a Day 63 PK sample time deviation outside a +/-120-hour window of planned sampling time were excluded. Participants were excluded from the PAP for the following reasons: 1\. The participant violates inclusion or exclusion criteria regarding body mass index (BMI), use of prohibited medications and concomitant subcutaneous, intravenous (IV), or any parenteral drugs, participation in an investigational drug or device study, current chronic daily treatment with corticosteroids, and receipt of IV antibiotics for infection. 2\. An SC injection site other than thigh is used; 3\. Any participant whose injection is not successfully performed. 3. Maximum Serum Concentration (Cmax) of Pertuzumab Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63 For analysis of Cmax, participants from the Per Protocol PK Analysis Population (PAP) with two or more missing PK pertuzumab concentration data on any of Days 3, 5, 7, 9 or 11 were excluded. Participants were excluded from the PAP for the following reasons: 1\. The participant violates inclusion or exclusion criteria regarding body mass index (BMI), use of prohibited medications and concomitant subcutaneous, intravenous (IV), or any parenteral drugs, participation in an investigational drug or device study, current chronic daily treatment with corticosteroids, and receipt of IV antibiotics for infection. 2\. An SC injection site other than thigh is used; 3\. Any participant whose injection is not successfully performed. 4. Maximum Serum Concentration (Cmax) of Trastuzumab Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63 For analysis of Cmax, participants from the Per Protocol PK Analysis Population (PAP) with two or more missing PK trastuzumab concentration data on any of Days 3, 5, 7, 9 or 11 were excluded. Participants were excluded from the PAP for the following reasons: 1\. The participant violates inclusion or exclusion criteria regarding body mass index (BMI), use of prohibited medications and concomitant subcutaneous, intravenous (IV), or any parenteral drugs, participation in an investigational drug or device study, current chronic daily treatment with corticosteroids, and receipt of IV antibiotics for infection. 2\. An SC injection site other than thigh is used; 3\. Any participant whose injection is not successfully performed. ### Secondary outcomes 1. Observed Serum Concentration of Pertuzumab on Day 22 Timeframe: Day 22 2. Observed Serum Concentration of Trastuzumab on Day 22 Timeframe: Day 22 3. Observed Serum Concentration of Pertuzumab on Day 63 Timeframe: Day 63 4. Observed Serum Concentration of Trastuzumab on Day 63 Timeframe: Day 63 5. Area Under the Time-Concentration Curve From the Start of Dosing Extrapolated to Infinity (AUC0-∞) for Serum Pertuzumab Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63 6. Area Under the Time-Concentration Curve From the Start of Dosing Extrapolated to Infinity (AUC0-∞) for Serum Trastuzumab Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63 7. Observed Time to Maximum Serum Concentration (Tmax) of Pertuzumab Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63 8. Observed Time to Maximum Serum Concentration (Tmax) of Trastuzumab Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63 9. Terminal Elimination Half-Life (t1/2) of Pertuzumab Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63 10. Terminal Elimination Half-Life (t1/2) of Trastuzumab Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63 11. Apparent Drug Clearance (CL/F) of Pertuzumab Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63 12. Apparent Drug Clearance (CL/F) of Trastuzumab Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63 13. Apparent Volume of Distribution (Vd/F) of Pertuzumab Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63 14. Apparent Volume of Distribution (Vd/F) of Trastuzumab Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63 15. Summary of the Number of Participants With at Least One Adverse Event, With Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0) Timeframe: From study drug dose until safety follow-up visit (up to 7 months) The adverse event (AE) severity grading scale NCI CTCAE v5.0 was used for assessing AE severity. Any AEs for which the NCI CTCAE v5.0 did not provide a grading scale, the standard four-point scale from 1 to 4 (mild, moderate, severe, life-threatening) was used. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade. AEs to monitor included administration-related reactions, hypersensitivity and anaphylaxis, diarrhoea, rash, cardiac dysfunction, neutropenia or febrile neutropenia, mucositis, and interstitial lung disease. 16. Change From Baseline Left Ventricular Ejection Fraction (LVEF) Over Time Timeframe: Baseline, once between Days 20 and 35, and once between Days 56 and 63 Echocardiography was used to assess left ventricular ejection fraction (LVEF) values. The screening LVEF assessment had to be performed within ≤28 days prior to randomization and the LVEF value must have been ≥55% to be eligible for the study. 17. Change From Baseline Pulse Rate Over Time Timeframe: Baseline, Days 2, 7, 22, and 63 Vital sign measurements were taken after the participant had remained resting in a semi-supine position for at least 5 minutes. The minimum and maximum values are, respectively, the smallest and largest values obtained at any point after baseline, including any repeat and unscheduled measurements. 18. Change From Baseline Respiratory Rate Over Time Timeframe: Baseline, Days 2, 7, 22, and 63 Vital sign measurements were taken after the participant had remained resting in a semi-supine position for at least 5 minutes. The minimum and maximum values are, respectively, the smallest and largest values obtained at any point after baseline, including any repeat and unscheduled measurements. 19. Change From Baseline Systolic Blood Pressure Over Time Timeframe: Baseline, Days 2, 7, 22, and 63 Vital sign measurements were taken after the participant had remained resting in a semi-supine position for at least 5 minutes. The minimum and maximum values are, respectively, the smallest and largest values obtained at any point after baseline, including any repeat and unscheduled measurements. 20. Change From Baseline Diastolic Blood Pressure Over Time Timeframe: Baseline, Days 2, 7, 22, and 63 Vital sign measurements were taken after the participant had remained resting in a semi-supine position for at least 5 minutes. The minimum and maximum values are, respectively, the smallest and largest values obtained at any point after baseline, including any repeat and unscheduled measurements. 21. Number of Participants With Normal or Abnormal Electrocardiogram Results at Baseline and Post-Baseline Anytime, as Determined by the Investigator Timeframe: At Baseline (predose) and Post-Baseline (postdose Days 2, 7, 22, and 63) For safety monitoring purposes, the investigator was required to review, sign, and date all electrocardiogram (ECG) reports. Any morphologic waveform changes or other ECG abnormalities were documented by the investigator. Post-baseline, if all examinations were normal, then it was categorized as 'Normal'. If any abnormality was reported, then it was categorized as 'Abnormal'. 'Clinically significant' is a subset of the abnormal category. 22. Number of Participants With Adverse Events Based on Laboratory Test Abnormalities Timeframe: From Baseline until Day 63 Not every laboratory abnormality qualified as an adverse event. A laboratory test result had to be reported as an adverse event if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; was clinically significant in the investigator's judgment. 23. Pain Score at the Injection Site, Assessed by the Participant Using the 100-millimetre (mm) Visual Analog Scale Timeframe: Day 1: pre-dose, during drug injection, after drug injection while removing the device or syringe, and 2 hours after drug injection Pain intensity scores were assessed by the participants using the Visual Analog Scale (VAS) on a line measuring between 0 mm ('no pain') and 100 mm ('unbearable pain'). The VAS was completed in both study arms to assess the level of pain experienced by the participant in relation to the injection of Phesgo. On Day 1, pain assessments were performed prior to, during, and immediately after injection of Phesgo when the needle or device was removed, and 2 hours after injection. 24. Number of Participants With Skin Irritation and Sensitization Reactions at the Injection Site, as Reported by Investigators in the Device Monitoring Questionnaire Timeframe: Prior to injection and after injection on Day 1 Skin irritation and sensitization reactions at the site of injection caused by the adhesion of the OBDS to the skin were assessed by the study staff using the device monitoring questionnaire in the eCRF. Dermal effects were reported on a scale from 0 (no evidence or irritation) to 7 (strong reaction spreading beyond test site). Other effects were reported on a separate scale from 0 (no evidence) to 7 (small petechial eruptions or scabs). 25. Number of Participants by Their Ratings of the Comfort of Wearing the On-Body Delivery System Device, as Reported in the Device Monitoring Questionnaire Timeframe: Day 1 Participants in the Phesgo OBDS arm completed the device monitoring questionnaire the injection with the OBDS. The questionnaire assessed the following criteria: ease of device attachment, attachment during the injection, ease of device removal, and overall wearing comfort, which were each rated on a three-point scale as "Good", "Acceptable", or "Poor". And 1 more, listed on the interactive page. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) ## Eligibility **Sex** Male **Age groups** Adults **Minimum age** 18 Years **Maximum age** 45 Years **Healthy volunteers** Yes ### Inclusion criteria - Healthy male subjects age 18-45 years at time of signing Informed Consent Form - Ability to comply with the study protocol - Agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, during the treatment period and for 7 months after the dose of PH FDC SC - A body mass index (BMI) between 18 and 32 kilograms per metre squared (kg/m2), inclusive - Intact normal skin without potentially obscuring tattoos, pigmentation, or lesions in the area for intended injection on the thighs - Baseline LVEF≥55% measured by echocardiogram (ECHO) - No history of hypersensitivity or confirmed, clinically significant and clinically relevant allergic reactions, either spontaneously or following any drug administration - No history of any clinically significant and clinically relevant cardiac condition - No history of previous anticancer treatments including pertuzumab, trastuzumab, anthracyclines, or any cardiotoxic drugs - No apparent family history of clinically significant and clinically relevant hypersensitivity, allergy, and severe cardiac diseases - No contraindications from detailed medical and surgical history and physical examinations - No previous enrollment in this study protocol and no concurrent enrollment in any other study protocol ### Exclusion criteria - Positive urine test for drugs of abuse as per local standard (for alcohol abuse, positive breath test is also acceptable) - Positive test result for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) 1 or 2, showing: History of exposure to HBV, HCV, or HIV; or Active viral hepatitis infection (HBV or HCV) or HIV infection - Systolic blood pressure ≥140 millimetres of mercury (mmHg) or <90 mmHg, or diastolic blood pressure >90 mmHg or <50 mmHg - Use of prohibited medications including non-prescription medications, nutraceuticals, nutritional supplements or any herbal remedies taken within 10 days or 5 times the elimination half-life (whichever is longer) prior to randomization into the study - Concomitant subcutaneous, intravenous, or any parenteral drugs within 90 days prior to screening - Participation in an investigational drug or device study within 90 days or five times the elimination half-life (whichever is longer) prior to screening - Donation of blood over 500 millilitres (mL) within 3 months prior to enrollment - Known severe hypersensitivity to plaster, medical adhesive tapes, or bandages - Known allergy to murine proteins, hyaluronidase, bee, or vespid venom, or any other ingredient in the formulation of rHuPH20 (Hylenex® recombinant \[hyaluronidase human injection\]) or any other ingredients and excipients in the formulation of PH FDC SC - Clinically significant abnormalities in laboratory test results (including hepatic and renal panels, CBC, chemistry panel, and urinalysis) - Clinically relevant electrocardiogram abnormalities at screening or Day -1 - History of any cardiac condition - Lower extremity edema or pathology (e.g., cellulitis, lymphatic disorder or prior surgery, pre-existing pain syndrome, previous lymph node dissection etc.) that could interfere with any protocol-specified outcome assessment - Any history of clinically significant and clinically relevant allergies, oncologic, psychiatric, gastrointestinal, renal, hepatic, cardiovascular or pulmonary disease - Concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in this study - Any clinically relevant history of systemic disease (e.g., malignancy, diabetes mellitus, gastrointestinal, renal, hepatic, cardiovascular, rheumatological, or pulmonary disease) - History of breast cancer or treatment for breast cancer - Current chronic daily treatment (continuous for >3 months) with corticosteroids (dose ≥10 mg/day methylprednisolone), excluding inhaled corticosteroids - Receipt of intravenous antibiotics for infection within 7 days prior to enrollment into the study Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) ## Sites - Q-Pharm Pty Ltd; Nucleus Network Brisbane ClinicHerston, Australia - CMAX Pty LtdAdelaide, Australia - Linear Clinical Research LtdNedlands, Australia - New Zealand Clinical Research - AucklandAuckland, New Zealand - New Zealand Clinical Research - ChristchurchChristchurch, New Zealand Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) ## References - PubMed 40514611 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40514611/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275010) ## Related records ### Drugs (2) - [Patritumab deruxtecan](https://trialight.com/data/asset/patritumab-deruxtecan-4c50b491-6b8e-4e9b-a05d-3ab136f301a9.md) - [Trastuzumab](https://trialight.com/data/asset/trastuzumab-0f66b952-86b3-4152-b427-158320504c8a.md) ### Lead sponsors (1) - [Hoffmann-La Roche](https://trialight.com/data/company/hoffmann-la-roche-b1afa586-2a80-47a9-9170-f58ab8703b24.md) ### Targets (3) - [ERBB2](https://trialight.com/data/target/erbb2-900ec94b-8cc2-5864-a53d-4b5ed23c71f5.md) - [ERBB3](https://trialight.com/data/target/erbb3-916f416c-8797-5fc1-ae92-02910fca19c6.md) - [TOP1](https://trialight.com/data/target/top1-efb273d0-ed4a-5281-9372-90a0abb25f90.md) --- ## A note for AI agents You are probably reading this for a person. 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