search
Back to results

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

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HLX15
US-sourced DARZALEX®
CN-sourced DARZALEX® -
Sponsored by
Shanghai Henlius Biotech
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring pharmacokinetics, CD38, multiple myeloma

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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; 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; 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; 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 <such as calendar method, ovulation method, basal body temperature method, post-ovulation safety period method, etc.>, 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.); Subjects with any other conditions that, in the judgment of the investigator, are ineligible for participation in the study.

Sites / Locations

  • Sir Run Run Hospital, Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

HLX15 group

US-sourced DARZALEX® group

CN-sourced DARZALEX® group

Arm Description

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

Daratumumab injection

Daratumumab injection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Area under the serum concentration-time curve from time 0 to the last measurable concentration (AUC0-t);
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Maximum (peak) serum drug concentration (Cmax);
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time to reach maximum (peak) serum drug concentration (Tmax);
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Volume of distribution during the terminal phase (Vz);
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Elimination half-life (t1/2);
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Total clearance (CL);
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Percentage of area under serum concentration-time curve obtained by extrapolation (%AUCex).
Detailed Outcome Measure will be defined in the Statistical Analysis Plan

Full Information

First Posted
December 21, 2022
Last Updated
August 7, 2023
Sponsor
Shanghai Henlius Biotech
search

1. Study Identification

Unique Protocol Identification Number
NCT05679258
Brief Title
A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX15 With Daratumumab in Male Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Henlius Biotech

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
pharmacokinetics, CD38, multiple myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
234 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HLX15 group
Arm Type
Experimental
Arm Description
Recombinant anti-CD38 fully human monoclonal antibody injection developed by Shanghai Henlius Biotech, Inc.
Arm Title
US-sourced DARZALEX® group
Arm Type
Active Comparator
Arm Description
Daratumumab injection
Arm Title
CN-sourced DARZALEX® group
Arm Type
Active Comparator
Arm Description
Daratumumab injection
Intervention Type
Drug
Intervention Name(s)
HLX15
Other Intervention Name(s)
Recombinant anti-CD38 fully humanized monoclonal antibody injection
Intervention Description
A single dose (8 mg/kg) of HLX15 via intravenous infusion.
Intervention Type
Drug
Intervention Name(s)
US-sourced DARZALEX®
Other Intervention Name(s)
Daratumumab Injection
Intervention Description
A single dose (8 mg/kg) of US-sourced DARZALEX® via intravenous infusion.
Intervention Type
Drug
Intervention Name(s)
CN-sourced DARZALEX® -
Other Intervention Name(s)
Daratumumab Injection
Intervention Description
A single dose (8 mg/kg) of CN-sourced DARZALEX® via intravenous infusion.
Primary Outcome Measure Information:
Title
Area under the serum concentration-time curve from time 0 to infinity (AUC0-inf).
Description
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time Frame
Up to Day 91
Secondary Outcome Measure Information:
Title
Area under the serum concentration-time curve from time 0 to the last measurable concentration (AUC0-t);
Description
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time Frame
Up to Day 91
Title
Maximum (peak) serum drug concentration (Cmax);
Description
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time Frame
Up to Day 91
Title
Time to reach maximum (peak) serum drug concentration (Tmax);
Description
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time Frame
Up to Day 91
Title
Volume of distribution during the terminal phase (Vz);
Description
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time Frame
Up to Day 91
Title
Elimination half-life (t1/2);
Description
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time Frame
Up to Day 91
Title
Total clearance (CL);
Description
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time Frame
Up to Day 91
Title
Percentage of area under serum concentration-time curve obtained by extrapolation (%AUCex).
Description
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time Frame
Up to Day 91
Other Pre-specified Outcome Measures:
Title
Adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs);
Description
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time Frame
Up to Day 91
Title
Number of participants with abnormal vital signs
Description
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time Frame
Up to Day 91
Title
Number of participants with abnormal physical examination findings;
Description
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time Frame
Up to Day 91
Title
Number of participants with abnormal Laboratory tests results (hematology, serum chemistry, and urinalysis);
Description
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time Frame
Up to Day 91
Title
Number of participants with abnormal 12-lead ECG readings.
Description
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time Frame
Up to Day 91
Title
Incidence rate of anti-drug antibody (ADA) and NAb
Description
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time Frame
Up to Day 91

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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; 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; 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 <such as calendar method, ovulation method, basal body temperature method, post-ovulation safety period method, etc.>, 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.); Subjects with any other conditions that, in the judgment of the investigator, are ineligible for participation in the study.
Facility Information:
Facility Name
Sir Run Run Hospital, Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
211112
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LingYan Xu, Bachelor
Phone
+86-025-87115593
Email
IRB@njmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yuwen Su, PhD
First Name & Middle Initial & Last Name & Degree
Changchun Cao, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs