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

NCT05679258 | Completed Phase 1

• 1 other identifier: HLX15-001
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Multiple Myeloma

Keywords

pharmacokinetics; CD38; multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Area under the serum concentration-time curve from time 0 to infinity (AUC0-inf).

  Detailed Outcome Measure will be defined in the Statistical Analysis Plan

  Up to Day 91

Secondary Outcomes (7)

• Area under the serum concentration-time curve from time 0 to the last measurable concentration (AUC0-t);

  Up to Day 91

• Maximum (peak) serum drug concentration (Cmax);

  Up to Day 91

• Time to reach maximum (peak) serum drug concentration (Tmax);

  Up to Day 91

• Volume of distribution during the terminal phase (Vz);

  Up to Day 91

• Elimination half-life (t1/2);

  Up to Day 91

Other Outcomes (6)

• Adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs);

  Up to Day 91

• Number of participants with abnormal vital signs

  Up to Day 91

• Number of participants with abnormal physical examination findings;

  Up to Day 91

Study Arms (4)

HLX15 group

EXPERIMENTAL

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

Drug: HLX15

US-sourced DARZALEX® group

ACTIVE COMPARATOR

Daratumumab injection

Drug: US-sourced DARZALEX®

CN-sourced DARZALEX® group

ACTIVE COMPARATOR

Daratumumab injection

Drug: CN-sourced DARZALEX®

EU-sourced DARZALEX® group

ACTIVE COMPARATOR

Daratumumab injection

Drug: EU-sourced DARZALEX®

Interventions

HLX15 DRUG

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

Also known as: Recombinant anti-CD38 fully humanized monoclonal antibody injection

HLX15 group

US-sourced DARZALEX® DRUG

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

Also known as: Daratumumab Injection

US-sourced DARZALEX® group

CN-sourced DARZALEX® DRUG

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

Also known as: Daratumumab Injection

CN-sourced DARZALEX® group

EU-sourced DARZALEX® DRUG

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

Also known as: Daratumumab Injection

EU-sourced DARZALEX® group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥ 18 years and ≤ 60 years at the time of signing the informed consent form (ICF);
• Sex: male;
• Body weight and body mass index (BMI): 18.5 kg/m2 ≤ BMI \< 28 kg/m2; body weight ≥ 55 kg;
• 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);
• The subject should be a voluntary participant who has understood and signed the ICF.

You may not qualify if:

• 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;
• With acute, chronic, or latent infectious diseases within 1 month before administration;
• With known immune system diseases (autoimmune diseases and immunodeficiency diseases), including but not limited to autoimmune hemolytic anemia;
• Has experienced a recent single dermatomal herpes zoster eruption within 6 months before administration;
• Has a history of multi-dermatomal herpes zoster or central nervous system (CNS) herpes zoster during the screening period or before;
• Positive for indirect antiglobulin test (Indirect Coombs test);
• Use of monoclonal antibody, cell therapy, etc. within 6 months before administration, or daratumumab or its analogues or drugs targeting CD38 before administration;
• Use of any medication, including prescription drugs, over-the-counter (OTC) drugs, and Chinese herbal medicines, within 2 weeks before administration;
• History of drug or food allergy, including allergy to any drug or drug excipient used in the study;
• 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);
• History of blood donation or total blood loss of 200 mL or more within 3 months before administration;
• 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;
• Major surgery within 3 months before signing the ICF;
• 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);
• History of drug abuse or substance abuse, or positive in urine drug screening;

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (2)

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

Location

Sir Run Run Hospital, Nanjing Medical University

Nanjing, Jiangsu, 211112, China

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

daratumumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 10, 2023
• Study Start: January 31, 2023
• Primary Completion: March 16, 2024
• Study Completion: June 28, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)