Comparing HLX13 and YERVOY in Healthy Male Volunteers

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

This study is testing a new treatment called HLX13 against YERVOY® in healthy Chinese men to see how safe it is and how it works in the body.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 304 (estimated)
• Ages: 18 Years to 60 Years
• Sex: Male
• Sponsor: Shanghai Henlius Biotech (Industry-sponsored)
• Locations: 1 site (Anhui, Anhui)
• Trial ID: NCT06159101 on ClinicalTrials.gov

What this trial studies

This Phase I study evaluates the pharmacokinetic characteristics, safety, tolerability, and immunogenicity of HLX13 compared to YERVOY® in healthy Chinese male subjects. The study is divided into two parts: the first part is an open-label, randomized, single-dose comparison of HLX13 with EU-sourced YERVOY®, while the second part is a double-blind, randomized, single-dose evaluation of the pharmacokinetic similarity of HLX13 and YERVOY® sourced from the US, EU, and China. Participants will receive a single intravenous infusion and will be monitored for safety and tolerability. This study aims to provide data that supports the development of HLX13 as a potential treatment option.

Who should consider this trial

Good fit: Ideal candidates are healthy Chinese males aged 18 to 60 with a BMI between 18.5 and 28 kg/m2.

Not a fit: Patients with significant medical history or those who have used monoclonal antibodies in the past six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option for conditions requiring CTLA-4 inhibition.

How similar studies have performed: Other studies have shown success with similar pharmacokinetic comparisons, but the specific approach of HLX13 is novel.

Eligibility criteria

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.

Where this trial is running

Anhui, Anhui

• The Second Hospital of Anhui Medical University — Anhui, Anhui, China (Recruiting)

Study contacts

• Principal investigator: Hu Wei — The Second Hospital of Anhui Medical University
• Study coordinator: Hu Wei

Conditions Healthy Male Volunteers; CTLA-4