Clinical trial NCT06159101: A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX13 With YERVOY in Male Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Male Volunteers
Keywords: CTLA-4
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2023-12-06
Enrollment: 304
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

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.

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.

Primary outcomes:
measure: Area under the serum concentration-time curve from time 0 to infinity (AUC0-inf)
timeFrame: Up to Day 90
measure: Maximum (peak) serum drug concentration (Cmax)
timeFrame: Up to Day 90
Secondary outcomes:
measure: Area under the serum concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)
timeFrame: Up to Day 90
measure: Percentage of area under the serum concentration-time curve extrapolated to infinity (%AUCex)
timeFrame: Up to Day 90
measure: Time to reach maximum (peak) serum drug concentration (Tmax)
timeFrame: Up to Day 90
measure: Elimination half life (t1/2)
timeFrame: Up to Day 90
measure: Total clearance (CL)
timeFrame: Up to Day 90
measure: Apparent volume of distribution during terminal phase (Vz)
timeFrame: Up to Day 90
measure: Mean residence time (MRT)
timeFrame: Up to Day 90
Other outcomes:
measure: Adverse events (AEs), serious adverse events (SAEs),
timeFrame: Up to Day 90
measure: Incidence of anti-drug antibodies (ADAs)
timeFrame: Up to Day 90
measure: Incidence of neutralizing antibodies (NAbs).
timeFrame: Up to Day 90
Locations:
city: Anhui
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
Study officials:
affiliation: The Second Hospital of Anhui Medical University
name: Hu Wei
role: PRINCIPAL_INVESTIGATOR
References: