A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX15 With Daratumumab in Male Subjects

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 60 Years
Gender Male
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Shanghai Henlius Biotech
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries China

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Additional Details

This study contains two parts. Part I of the study is a single-center, randomized, open-label, 2-arm, parallel-controlled phase Ia study to compare the PK characteristics, safety, tolerability, and immunogenicity of HLX15 and daratumumab infusion (DARZALEX®, CN-sourced) in healthy Chinese male subjects. A total of 24 healthy Chinese male subjects will be enrolled in this part and randomized to the HLX15 group or the CN-sourced DARZALEX® group in a 1:1 ratio, with 12 subjects in each group. The subjects will receive a single dose (8 mg/kg) of HLX15 or CN-sourced DARZALEX® via intravenous infusion. There is a safety run-in period in the early stage of the study to investigate the safety and tolerability of HLX15 in healthy Chinese male subjects. Another 3-6 subjects will be enrolled to receive the investigational product HLX15 and safety observation will be conducted for 1 week. The Safety Review Committee (SRC) will decide whether to adjust the subsequent study plan based on the safety and tolerability data after administration. Part II of the study is a multicenter, randomized, double-blind, 3-arm, parallel-controlled phase Ib study to compare similarity of the PK characteristics, safety, tolerability, and immunogenicity of HLX15 and daratumumab infusion (DARZALEX®, US-sourced; DARZALEX®, CN-sourced) in healthy Chinese male subjects.A total of 204 healthy Chinese male subjects are planned to be enrolled in this part and randomly assigned in a 1:1:1 ratio to the HLX15 group, the US-sourced DARZALEX® group, or the CN-sourced DARZALEX® group, with 68 subjects in each group. The subjects will receive a single dose (8 mg/kg) of HLX15, US-sourced DARZALEX®, or CN-sourced DARZALEX® via intravenous infusion.This part may be adjusted according to the results of Part I, including sample size and sampling time points

Arms & Interventions


Experimental: HLX15 group

Recombinant anti-CD38 fully human monoclonal antibody injection developed by Shanghai Henlius Biotech, Inc.

Active Comparator: US-sourced DARZALEX® group

Daratumumab injection

Active Comparator: CN-sourced DARZALEX® group

Daratumumab injection


Drug: - HLX15

A single dose (8 mg/kg) of HLX15 via intravenous infusion.

Drug: - US-sourced DARZALEX®

A single dose (8 mg/kg) of US-sourced DARZALEX® via intravenous infusion.

Drug: - CN-sourced DARZALEX® -

A single dose (8 mg/kg) of CN-sourced DARZALEX® via intravenous infusion.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Nanjing, Jiangsu, China




Sir Run Run Hospital, Nanjing Medical University

Nanjing, Jiangsu, 211112

Site Contact

LingYan Xu, Bachelor