A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX13 With YERVOY in Male Subjects

A Randomized, Intravenous Single-Dose, Parallel, Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX13 and YERVOY® (US-, EU-, and CN-Sourced) in Healthy Chinese Male Subjects

Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, Tolerability, and Immunogenicity (Randomized, Double-blind, Parallel Controlled) of HLX13 with YERVOY® Injection in Healthy Chinese Male Subjects

Study Overview

• Status: Recruiting
• Conditions: Healthy Male Volunteers
• Intervention / Treatment: Drug: HLX13; Drug: CN-sourced ipilimumab; Drug: EU-sourced ipilimumab group; Drug: US-sourced ipilimumab group

Detailed Description

This is a randomized, intravenous single-dose, parallel study to compare the PK characteristics of HLX13 and YERVOY® (US-, EU-, and CN-sourced) and evaluate their safety, tolerability, and immunogenicity in healthy Chinese male subjects.

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.

• Study Type: Interventional
• Enrollment (Estimated): 304
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Hu Wei; Phone Number: +86-0551-65997165

Study Locations

• China
  • Anhui
    • Anhui, Anhui, China
      • Recruiting
      • The Second Hospital of Anhui Medical University
      • Contact: Hu Wei; Phone Number: +86-0551-65997165

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Willing to sign the informed consent form.
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:

1. History of any severe hematological or renal, endocrinic, respiratory, gastrointestinal, cardiovascular, hepatic, neuropsychiatric, or neurological diseases or tumors.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HLX13 group; Recombinant anti-CTLA-4 fully human monoclonal antibody injection developed by Shanghai Henlius Biotech, Inc.	Drug: HLX13; A single dose (0.3 mg/kg) of HLX13 via intravenous infusion.
Active Comparator: CN-sourced ipilimumab group; CN-sourced ipilimumab	Drug: CN-sourced ipilimumab; A single dose (0.3 mg/kg) of CN-sourced ipilimumab via intravenous infusion.
Active Comparator: EU-sourced ipilimumab group; EU-sourced ipilimumab	Drug: EU-sourced ipilimumab group; A single dose (0.3 mg/kg) of EU-sourced ipilimumab via intravenous infusion.
Active Comparator: US-sourced ipilimumab group; US-sourced ipilimumab	Drug: US-sourced ipilimumab group; A single dose (0.3 mg/kg) of US-sourced ipilimumab via intravenous infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 90
Maximum (peak) serum drug concentration (Cmax)	Detailed Outcome Measure will be defined in the Statistical Analysis Plan	Up to Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the serum concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)	Detailed Outcome Measure will be defined in the Statistical Analysis Plan	Up to Day 90
Percentage of area under the serum concentration-time curve extrapolated to infinity (%AUCex)	Detailed Outcome Measure will be defined in the Statistical Analysis Plan	Up to Day 90
Time to reach maximum (peak) serum drug concentration (Tmax)	Detailed Outcome Measure will be defined in the Statistical Analysis Plan	Up to Day 90
Elimination half life (t1/2)	Detailed Outcome Measure will be defined in the Statistical Analysis Plan	Up to Day 90
Total clearance (CL)	Detailed Outcome Measure will be defined in the Statistical Analysis Plan	Up to Day 90
Apparent volume of distribution during terminal phase (Vz)	Detailed Outcome Measure will be defined in the Statistical Analysis Plan	Up to Day 90
Mean residence time (MRT)	Detailed Outcome Measure will be defined in the Statistical Analysis Plan	Up to Day 90

Other Outcome Measures

Outcome Measure	Time Frame
Adverse events (AEs), serious adverse events (SAEs),	Up to Day 90
Incidence of anti-drug antibodies (ADAs)	Up to Day 90
Incidence of neutralizing antibodies (NAbs).	Up to Day 90

Collaborators and Investigators

• Sponsor: Shanghai Henlius Biotech
• Investigators: Principal Investigator: Hu Wei, The Second Hospital of Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2023
• Primary Completion (Estimated): May 28, 2024
• Study Completion (Estimated): May 28, 2024

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Estimated): December 6, 2023

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: CTLA-4
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Ipilimumab
• Other Study ID Numbers: HLX13-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No