A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX13 With YERVOY in Male Subjects
NCT ID: NCT06159101
Last Updated: 2023-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
304 participants
INTERVENTIONAL
2023-11-28
2024-05-28
Brief Summary
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Detailed Description
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This study is divided into two parts. Part I is an open-label, randomized, single-dose, parallel study to compare the PK parameters of HLX13 with those of EU-sourced YERVOY® in healthy Chinese male subjects after a single intravenous infusion and provide supporting data for the design of Part II. This part of the study consists of two groups.
Part II is a double-blind, randomized, single-dose, parallel study to evaluate the PK similarity of HLX 13 and YERVOY® (US-, EU-, and CN-sourced) in healthy Chinese male subjects. This part of the study consists of four groups.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HLX13 group
Recombinant anti-CTLA-4 fully human monoclonal antibody injection developed by Shanghai Henlius Biotech, Inc.
HLX13
A single dose (0.3 mg/kg) of HLX13 via intravenous infusion.
CN-sourced ipilimumab group
CN-sourced ipilimumab
CN-sourced ipilimumab
A single dose (0.3 mg/kg) of CN-sourced ipilimumab via intravenous infusion.
EU-sourced ipilimumab group
EU-sourced ipilimumab
EU-sourced ipilimumab group
A single dose (0.3 mg/kg) of EU-sourced ipilimumab via intravenous infusion.
US-sourced ipilimumab group
US-sourced ipilimumab
US-sourced ipilimumab group
A single dose (0.3 mg/kg) of US-sourced ipilimumab via intravenous infusion.
Interventions
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HLX13
A single dose (0.3 mg/kg) of HLX13 via intravenous infusion.
CN-sourced ipilimumab
A single dose (0.3 mg/kg) of CN-sourced ipilimumab via intravenous infusion.
EU-sourced ipilimumab group
A single dose (0.3 mg/kg) of EU-sourced ipilimumab via intravenous infusion.
US-sourced ipilimumab group
A single dose (0.3 mg/kg) of US-sourced ipilimumab via intravenous infusion.
Eligibility Criteria
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Inclusion Criteria
2. Healthy Chinese males (no significant clinical abnormalities in medical history, physical examination, vital signs, chest X-ray, 12-lead ECG, and laboratory examinations).
3. Age ≥ 18 and ≤ 60 years old.
4. Body mass index (BMI) ≥ 18.5 and ≤ 28 kg/m2.
5. Left ventricular ejection fraction (LVEF) \> 50%, as measured by echocardiography within 14 days before randomization.
6. Subjects either agree that they and their spouse/partner will take reliable contraceptive measures within 3 months after the end of drug infusion or be infertile.
Exclusion Criteria
2. Use of a monoclonal antibody or any biological product within 6 months prior to the study treatment.
3. History of allergy or anaphylaxis, including that due to any drug or drug excipients in clinical studies.
4. Use of prescription/over-the-counter drugs or traditional Chinese medicines (except vitamins, mineral supplements, and health products) within 28 days prior to the study treatment.
5. History of blood donation within 3 months prior to the study treatment.
6. Participation in another clinical study and use of a clinical investigational drug or reference product within 3 months prior to the study treatment, or planning to participate in another drug clinical trial during the study period.
7. Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody.
8. History of drug abuse, or positive urine drug screen during the screening period.
9. Have undergone surgery within 3 months before screening or plan to undergo surgery during the study period; have undergone surgery that will affect drug absorption, distribution, metabolism, and excretion.
10. Have been vaccinated within 28 days prior to screening or plan to be vaccinated during the study.
11. Intolerant to venipuncture or with a history of needle or blood phobia.
12. People on special diets who reject the arranged meals.
13. Smoking more than 5 cigarettes per day within 3 months before screening or cannot stop using any tobacco products during the study.
14. An average daily alcohol intake of more than 15 g (equivalent to 450 mL beer or 150 mL wine or 50 mL low-alcohol liquor) within 1 month prior to screening; or a positive blood alcohol test at screening; or unwilling or unable to abstain from alcohol during the study.
15. Failure to comply with protocol requirements and instructions, protocol restrictions, etc., as judged by the investigator; uncooperative or unable to return to the study site for follow-up visits or complete the entire clinical study process, etc.
18 Years
60 Years
MALE
Yes
Sponsors
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Shanghai Henlius Biotech
INDUSTRY
Responsible Party
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Principal Investigators
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Hu Wei
Role: PRINCIPAL_INVESTIGATOR
The Second Hospital of Anhui Medical University
Locations
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The Second Hospital of Anhui Medical University
Anhui, Anhui, China
Countries
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Central Contacts
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Hu Wei
Role: CONTACT
Phone: +86-0551-65997165
Facility Contacts
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Hu Wei
Role: primary
Other Identifiers
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HLX13-001
Identifier Type: -
Identifier Source: org_study_id