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Mass Balance Study of [14C]HLX208 in China Healthy Subjects

Phase 1
Completed
Conditions
Mass Balance Study in Healthy Subjects
Interventions
Registration Number
NCT05841940
Lead Sponsor
Shanghai Henlius Biotech
Brief Summary

Mass Balance Study of \[14C\]HLX208 in China Healthy Subjects.

Detailed Description

A phase I study to quantify the total mass balance in healthy subjects after a single dose of \[14C\]HLX208.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
6
Inclusion Criteria
  1. Healthy male subjects between the ages of 18 and 45 years (inclusive).
  2. Subjects weighing ≥ 50 kg and Body Mass Index of 18.0 to 32.0 kg/m2.
  3. No sperm donation or fertility plan during the study and within 12 months after the end of the study.
  4. Subjects who have voluntarily participated in the study and signed the informed consent form with good compliance.
Exclusion Criteria
  1. Known history of drug or food allergy.
  2. Known medical history judged by the investigator as not suitable for the study.
  3. Has laboratory or physical examination abnormalities during the screening period.
  4. Has a positive test for, HBV,HCV,HIV,or syphilis.
  5. Has drug abuse history or positive drug abuse test results.
  6. Has diseases affecting the absorption, distribution, metabolism, and excretion of oral drugs.
  7. Has any other conditions judged by the investigator as not suitable for the study.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
[14C]HLX208[14C]HLX208Single oral dose of 450mg \[14C\]HLX208 suspension.
Primary Outcome Measures
NameTimeMethod
Mass balance recovery of total radioactivity in urine and fecal samples.Up to 336 hours post dose.

Mass balance recovery of total radioactivity in urine and fecal samples.

Total radioactivity in plasma PK: TmaxUp to 240 hours post dose.

Time for Cmax

Total rradioactivity in plasma PK: t1/2Up to 240 hours post dose.

Elimination half-life.

Total radioactivity in plasma PK: Vz/FUp to 240 hours post dose.

Apparent volume of distribution following oral administration.

Total radioactivity in plasma PK: CmaxUp to 240 hours post dose.

Maximum plasma concentration

Total radioactivity in plasma PK: AUC0-tUp to 240 hours post dose.

Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration.

Total radioactivity in plasma PK: AUC0-∞Up to 240 hours post dose.

Area under the plasma concentration time profile from time 0 to infinity.

Total radioactivity in plasma PK: CL/FUp to 240 hours post dose.

Drug clearance.

Secondary Outcome Measures
NameTimeMethod
HLX208 and metabolite PK: t1/2Up to 240 hours post dose.

Elimination half-life.

Adverse eventsScreening up to Day 15

Number of adverse events, which are any untoward medical occurrence regardless of attribution to study drug in a participant who received study drug.

HLX208 and metabolite PK: CmaxUp to 240 hours post dose.

Maximum plasma concentration

HLX208 and metabolite PK: AUC0-tUp to 240 hours post dose.

Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration.

HLX208 and metabolite PK: AUC0-∞Up to 240 hours post dose.

Area under the plasma concentration time profile from time 0 to infinity.

HLX208 and metabolite PK: TmaxUp to 240 hours post dose.

Time for Cmax

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University

🇨🇳

Suzhou, Jiangsu, China

The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
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