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

Launched by SHANGHAI HENLIUS BIOTECH · Dec 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called HLX13 and comparing it to an existing treatment known as YERVOY. The goal is to see how well these treatments work in healthy Chinese men, focusing on how the body processes the medication, how safe it is, and how well the body responds to it. The study is currently looking for male participants aged 18 to 60 who are in good health and meet certain criteria, such as having a normal medical history and specific health measurements.

Participants in this trial can expect to receive either HLX13 or YERVOY in a controlled setting, meaning neither they nor the researchers will know which treatment they are getting at first. This helps ensure the results are unbiased. Throughout the study, participants will undergo health checks and monitoring to track their progress and any side effects. It's important for potential participants to be aware that they shouldn't have serious health issues, recent surgeries, or certain medical histories that could affect their participation. If you meet the eligibility criteria and are interested, this trial may offer a chance to contribute to important research while monitoring your health closely.

Gender

MALE

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.