> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-compare-the-pk-safety-tolerability-and-db8c336c-254a-47aa-ae81-ff471168d7d3 > Record changed: 2026-10-13 # A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX15 With Daratumumab in Male Subjects NCT05679258 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) Participants 172 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) Lead sponsor Shanghai Henlius Biotech Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) Start date 2023-01-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) ## Title and summary **Summary** Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, Tolerability, and Immunogenicity (Randomized, Double-blind, Parallel Controlled) of HLX15 with Daratumumab Injection in Healthy Chinese Male Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) **Short title** A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX15 With Daratumumab in Male Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) **Official title** A Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, Tolerability, and Immunogenicity (Randomized, Double-blind, Parallel Controlled) of HLX15 With Daratumumab Injection in Healthy Chinese Male Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) ## Dates **Completion date** 2024-06-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) **First posted** 2023-01-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) **Registry last updated** 2024-06-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) **Primary completion date** 2024-03-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) **Start date** 2023-01-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) ## Size and sites **Actual participants** 172 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) **Participants** 172 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) **Lead sponsor** Shanghai Henlius Biotech Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) ## Identifiers **Registry ID** NCT05679258 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) **ClinicalTrials.gov ID** NCT05679258 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) ## Outcomes ### Primary outcomes 1. Area under the serum concentration-time curve from time 0 to infinity (AUC0-inf). Timeframe: Up to Day 91 Detailed Outcome Measure will be defined in the Statistical Analysis Plan ### Secondary outcomes 1. Area under the serum concentration-time curve from time 0 to the last measurable concentration (AUC0-t); Timeframe: Up to Day 91 Detailed Outcome Measure will be defined in the Statistical Analysis Plan 2. Maximum (peak) serum drug concentration (Cmax); Timeframe: Up to Day 91 Detailed Outcome Measure will be defined in the Statistical Analysis Plan 3. Time to reach maximum (peak) serum drug concentration (Tmax); Timeframe: Up to Day 91 Detailed Outcome Measure will be defined in the Statistical Analysis Plan 4. Volume of distribution during the terminal phase (Vz); Timeframe: Up to Day 91 Detailed Outcome Measure will be defined in the Statistical Analysis Plan 5. Elimination half-life (t1/2); Timeframe: Up to Day 91 Detailed Outcome Measure will be defined in the Statistical Analysis Plan 6. Total clearance (CL); Timeframe: Up to Day 91 Detailed Outcome Measure will be defined in the Statistical Analysis Plan 7. Percentage of area under serum concentration-time curve obtained by extrapolation (%AUCex). Timeframe: Up to Day 91 Detailed Outcome Measure will be defined in the Statistical Analysis Plan Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) ## Eligibility **Sex** Male **Age groups** Adults **Minimum age** 18 Years **Maximum age** 60 Years **Healthy volunteers** Yes ### Inclusion criteria 1. Age ≥ 18 years and ≤ 60 years at the time of signing the informed consent form (ICF); 2. Sex: male; 3. Body weight and body mass index (BMI): 18.5 kg/m2 ≤ BMI < 28 kg/m2; body weight ≥ 55 kg; 4. The subject should be judged by the physician to be in good general health according to the results of medical history, physical examination, vital signs, ECG examination, laboratory tests, etc. (normal or abnormal without clinical significance); 5. The subject should be a voluntary participant who has understood and signed the ICF. ### Exclusion criteria 1. Subjects who may have diseases that affect their safety or affect the study results, including but not limited to cardiovascular, respiratory, endocrine, metabolic, renal, hepatic, gastrointestinal tract, skin, infection, malignant tumor, hematologic, skeletal, genitourinary, nervous system/ psychiatric or functional disorders, which are judged as clinically significant by the investigator; 2. With acute, chronic, or latent infectious diseases within 1 month before administration; 3. With known immune system diseases (autoimmune diseases and immunodeficiency diseases), including but not limited to autoimmune hemolytic anemia; 4. Has experienced a recent single dermatomal herpes zoster eruption within 6 months before administration; 5. Has a history of multi-dermatomal herpes zoster or central nervous system (CNS) herpes zoster during the screening period or before; 6. Positive for indirect antiglobulin test (Indirect Coombs test); 7. Use of monoclonal antibody, cell therapy, etc. within 6 months before administration, or daratumumab or its analogues or drugs targeting CD38 before administration; 8. Use of any medication, including prescription drugs, over-the-counter (OTC) drugs, and Chinese herbal medicines, within 2 weeks before administration; 9. History of drug or food allergy, including allergy to any drug or drug excipient used in the study; 10. Fear of needles or blood, or difficulty in venous blood collection (history of difficult blood collection or corresponding symptoms and signs, unable to tolerate venipuncture); 11. History of blood donation or total blood loss of 200 mL or more within 3 months before administration; 12. Participants in clinical trials of any other drug or device within 3 months (or 5 half-lives of the corresponding investigational product if the half-life of the drug is long (5 half-lives > 3 months)) before administration; 13. Major surgery within 3 months before signing the ICF; 14. Positive for hepatitis B virus (HBsAg or HBcAb-positive) antibodies, hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV), or treponema pallidum antibodies (Anti-TP); 15. History of drug abuse or substance abuse, or positive in urine drug screening; 16. Patients who have been vaccinated with attenuated or live virus vaccine (such as Bacille Calmette-Guérin, BCG) or viral vector vaccine within 12 months before the first dose, or who plan to be vaccinated with such vaccines within 12 months after administration; 17. Patients who have been vaccinated with vaccines other than the above attenuated or live viral vaccines and viral vector vaccines within 1 month before the first dose, such as inactivated vaccines and recombinant subunit vaccines; 18. Male subjects with partners of childbearing potential who have a plan to father a child and/or donate sperm from signing of ICF through 3 months after administration, do not agree to abstain completely from sexual intercourse, or plan to use a contraceptive method that is not acceptable to the investigator (unacceptable methods of contraception include: i. periodic abstinence , withdrawal, etc.; ii. medical contraceptive measures such as oral contraceptives, contraceptive injections, contraceptive patches, subcutaneous implantation, intrauterine hormone contraceptive devices, local contraceptives such as spermicides, etc.); 19. Subjects with any other conditions that, in the judgment of the investigator, are ineligible for participation in the study. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) ## Sites - Beijing HospitalBeijing, China - Sir Run Run Hospital, Nanjing Medical UniversityNanjing, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05679258) ## Related records ### Drugs (2) - [Daratumumab](https://trialight.com/data/asset/daratumumab-28c327e5-1741-4dd5-89d4-6562e941ab50.md) - [Ustekinumab](https://trialight.com/data/asset/ustekinumab-323cb2e2-e906-4997-ac57-d82c7f7c399d.md) ### Lead sponsors (1) - [Shanghai Henlius Biotech](https://trialight.com/data/company/shanghai-henlius-biotech-aec8d786-7c6e-4c63-86f6-2a3a648aa0f1.md) ### Conditions (1) - [Plasma cell myeloma](https://trialight.com/data/condition/plasma-cell-myeloma-37186689-2591-5775-9042-2f2bf046a2b5.md) Primary condition ### Targets (4) - [CD38](https://trialight.com/data/target/cd38-a5ca1a53-c2f5-5b8e-9449-680140448931.md) - [IL12A](https://trialight.com/data/target/il12a-f7e63dfd-cd53-5ed7-ab6b-30bc302a7278.md) - [IL12B](https://trialight.com/data/target/il12b-92e53178-7b56-555c-ac6b-a1235d8fe7e5.md) - [IL23A](https://trialight.com/data/target/il23a-e11f3992-27b4-5bef-9242-07ab6ac420e9.md) --- ## A note for AI agents You are probably reading this for a person. 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