A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX13 With YERVOY in Male Subjects
- 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
- Short title
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2024-05-28
- First posted
- 2023-12-06
- Registry last updated
- 2023-12-06
- Primary completion date
- 2024-05-28
- Start date
- 2023-11-28
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Shanghai Henlius Biotech
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06159101
- ClinicalTrials.gov ID
- NCT06159101
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Area under the serum concentration-time curve from time 0 to infinity (AUC0-inf)
Timeframe: Up to Day 90
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Maximum (peak) serum drug concentration (Cmax)
Timeframe: Up to Day 90
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
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
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Percentage of area under the serum concentration-time curve extrapolated to infinity (%AUCex)
Timeframe: Up to Day 90
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time to reach maximum (peak) serum drug concentration (Tmax)
Timeframe: Up to Day 90
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Elimination half life (t1/2)
Timeframe: Up to Day 90
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Total clearance (CL)
Timeframe: Up to Day 90
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Apparent volume of distribution during terminal phase (Vz)
Timeframe: Up to Day 90
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Mean residence time (MRT)
Timeframe: Up to Day 90
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
- Sex
- Male
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 60 Years
- Healthy volunteers
- Yes
- Willing to sign the informed consent form.
- Healthy Chinese males (no significant clinical abnormalities in medical history, physical examination, vital signs, chest X-ray, 12-lead ECG, and laboratory examinations).
- Age ≥ 18 and ≤ 60 years old.
- Body mass index (BMI) ≥ 18.5 and ≤ 28 kg/m2.
- Left ventricular ejection fraction (LVEF) > 50%, as measured by echocardiography within 14 days before randomization.
- 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.
- History of any severe hematological or renal, endocrinic, respiratory, gastrointestinal, cardiovascular, hepatic, neuropsychiatric, or neurological diseases or tumors.
- Use of a monoclonal antibody or any biological product within 6 months prior to the study treatment.
- History of allergy or anaphylaxis, including that due to any drug or drug excipients in clinical studies.
- 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.
- History of blood donation within 3 months prior to the study treatment.
- 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.
- Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody.
- History of drug abuse, or positive urine drug screen during the screening period.
- 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.
- Have been vaccinated within 28 days prior to screening or plan to be vaccinated during the study.
- Intolerant to venipuncture or with a history of needle or blood phobia.
- People on special diets who reject the arranged meals.
- Smoking more than 5 cigarettes per day within 3 months before screening or cannot stop using any tobacco products during the study.
- 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.
- 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.
- The Second Hospital of Anhui Medical UniversityAnhui, ChinaRecruiting