> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-1-comparative-study-to-evaluate-pharmacokinetics-97e744d6-46f2-48b5-8bef-69f3a4565e15 > Record changed: 2026-10-13 # A Phase 1 Comparative Study to Evaluate Pharmacokinetics, Immunogenicity, Safety and Tolerability of Bmab3000 and Herceptin Hylecta® After a Single 600 mg SC Injection in Healthy Male Volunteers NCT07299955 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) Participants 150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) Lead sponsor Biocon Biologics UK PLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) Start date 2026-02-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) ## Title and summary **Summary** This phase I study is to compare the pharmacokinetics (PK), immunogenicity, safety, and tolerability of Bmab3000 (test) and Herceptin Hylecta (reference) after a single subcutaneous (s.c.) dose in healthy male volunteers. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) **Short title** A Phase 1 Comparative Study to Evaluate Pharmacokinetics, Immunogenicity, Safety and Tolerability of Bmab3000 and Herceptin Hylecta® After a Single 600 mg SC Injection in Healthy Male Volunteers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) **Official title** A Phase 1, Randomized, Double-Blind, Two-arm, Parallel Design, Comparative Study to Assess Pharmacokinetics, Immunogenicity, Safety and Tolerability of Bmab3000 and Herceptin Hylecta® Following a Single Dose of 600 mg Subcutaneous Injection in Healthy Male Volunteers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) ## Dates **Completion date** 2026-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) **First posted** 2025-12-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) **Registry last updated** 2026-04-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) **Primary completion date** 2026-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) **Start date** 2026-02-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) ## Size and sites **Participants** 150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) **Planned participants** 150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) **Lead sponsor** Biocon Biologics UK PLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) ## Identifiers **Registry ID** NCT07299955 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) **ClinicalTrials.gov ID** NCT07299955 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) ## Outcomes ### Primary outcomes 1. Cmax Timeframe: Day 1 to Day 91 Maximum observed concentration (Cmax) of drug Bmab 3000 2. AUCo-∞ Timeframe: Day 1 to Day 91 Comparison of area under the concentration-time curve from time 0 to infinity (AUC0-inf) ### Secondary outcomes 1. AUCo-t Timeframe: Day 1 to Day 91 Area Under the serum Concentration versus time curve from time 0 to the last sampling time at which concentrations were at or above the limit of quantification 2. Tmax Timeframe: Day 1 to Day 91 Time to maximum observed concentration 3. Vd/F Timeframe: Day 1 to Day 91 Volume of distribution 4. Cl/F Timeframe: Day 1 to Day 91 drug clearance 5. t1/2 Timeframe: Day 1 to Day 91 Apparent terminal elimination half-life 6. AUC% extrapolation Timeframe: Day 1 to Day 91 % of the AUC that has been derived after extrapolation 7. λz Timeframe: Day 1 to Day 91 Elimination rate constant Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) ## Eligibility **Sex** Male **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** Yes ### Inclusion criteria 1. Healthy male volunteers aged between 18 to 65 years; both inclusive. 2. Body weight ≥50 kg and ≤100 kg with body mass index (BMI) between 18.5 and 30 kg/m2, both inclusive. 3. Participants should have Left ventricular ejection fraction (LVEF) ≥55%. 4. Male participants must be using an acceptable method of contraception for the entire duration of the trial, and for at least three months after the trial drug administration. Participants must refrain from fathering a child or donating sperm in the next three months following the last trial drug administration or undergoing vasectomy. 5. All non-prescription medications must have been discontinued at least 14 days prior to dosing. 6. All non-topical prescription medications must have been stopped at least 30 days prior to admission to the clinical research center. 7. Absence of significant findings in the vital signs, 12 lead ECG, and clinical laboratory tests of blood and urine. 8. Willing and able to sign the informed consent form (ICF). ### Exclusion criteria 1. History of previous exposure to trastuzumab. 2. Presence of clinically significant medical history and clinically significant findings in the physical examination. 3. Allergy or hypersensitivity to trastuzumab, other recombinant human or humanized antibodies, other related products, or any excipients/ ingredients (e.g. hyaluronidase). 4. Sick sinus syndrome or known long QT syndrome (QTcF >450 msec). 5. Pronounced sinus bradycardia (<40 bpm), even if elicited by sport. 6. History of relevant drug and/or food allergies. 7. Positive urine drug and breath alcohol screen. 8. Consumption of any foods containing poppy seeds within 48 hours (2 days) prior to screening/admission to the clinical research center. 9. Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis virus (HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 and 2 antibodies. 10. Donation or loss of blood prior to drug administration. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) ## Sites - New Zealand Clinical Research (NZCR)Christchurch, New ZealandRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) ## References ### Other registry identifiers - U1111-1329-7865 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299955) ## Related records ### Drugs (1) - [Trastuzumab](https://trialight.com/data/asset/trastuzumab-0f66b952-86b3-4152-b427-158320504c8a.md) ### Lead sponsors (1) - [Biocon Biologics UK Ltd](https://trialight.com/data/company/biocon-biologics-uk-ltd-7368b8f2-3620-4a03-9901-e4e29bd7dc6e.md) ### Targets (1) - [ERBB2](https://trialight.com/data/target/erbb2-900ec94b-8cc2-5864-a53d-4b5ed23c71f5.md) --- ## A note for AI agents You are probably reading this for a person. 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