Neoplasms

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All Conditions

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Neoplasms, Plasma Cell

Neoplasms by Histologic Type

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Blood Protein Disorders

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All Drugs and Chemicals

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Antibodies

Antibodies, Monoclonal

Daratumumab

Immunoglobulins

Immunologic Factors

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

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

HLX15

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

US-sourced DARZALEX®

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

CN-sourced DARZALEX®

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

EU-sourced DARZALEX®

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

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

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

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

Detailed Outcome Measure will be defined in the Statistical Analysis Plan

Shanghai Henlius Biotech

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX15 With Daratumumab in Male Subjects	NCT05679258	Multiple Myelom...	HLX15 US-sourced DARZ... CN-sourced DARZ... EU-sourced DARZ...	18 Years - 60 Years	Shanghai Henlius Biotech
A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX15 With Daratumumab in Male Subjects	NCT05679258	Multiple Myelom...	HLX15 US-sourced DARZ... CN-sourced DARZ... EU-sourced DARZ...	18 Years - 60 Years	Shanghai Henlius Biotech
A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX15 With Daratumumab in Male Subjects	NCT05679258	Multiple Myelom...	HLX15 US-sourced DARZ... CN-sourced DARZ... EU-sourced DARZ...	18 Years - 60 Years	Shanghai Henlius Biotech

Spots Global Cancer Trial Database for hlx15

Every month we try and update this database with for hlx15 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hlx15

Every month we try and update this database with for hlx15 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hlx15 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.