Mass Balance Study of [14C]HLX208 in China Healthy Subjects
Study Details
Study Description
Brief Summary
Mass Balance Study of [14C]HLX208 in China Healthy Subjects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
A phase I study to quantify the total mass balance in healthy subjects after a single dose of [14C]HLX208.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: [14C]HLX208 Single oral dose of 450mg [14C]HLX208 suspension. |
Drug: [14C]HLX208
Carbon-14 labeled HLX208
|
Outcome Measures
Primary Outcome Measures
- 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: Cmax [Up to 240 hours post dose.]
Maximum plasma concentration
- Total radioactivity in plasma PK: Tmax [Up to 240 hours post dose.]
Time for Cmax
- Total radioactivity in plasma PK: AUC0-t [Up 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 rradioactivity in plasma PK: t1/2 [Up to 240 hours post dose.]
Elimination half-life.
- Total radioactivity in plasma PK: CL/F [Up to 240 hours post dose.]
Drug clearance.
- Total radioactivity in plasma PK: Vz/F [Up to 240 hours post dose.]
Apparent volume of distribution following oral administration.
Secondary Outcome Measures
- HLX208 and metabolite PK: Cmax [Up to 240 hours post dose.]
Maximum plasma concentration
- HLX208 and metabolite PK: Tmax [Up to 240 hours post dose.]
Time for Cmax
- HLX208 and metabolite PK: AUC0-t [Up 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: t1/2 [Up to 240 hours post dose.]
Elimination half-life.
- Adverse events [Screening 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy male subjects between the ages of 18 and 45 years (inclusive).
-
Subjects weighing ≥ 50 kg and Body Mass Index of 18.0 to 32.0 kg/m2.
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No sperm donation or fertility plan during the study and within 12 months after the end of the study.
-
Subjects who have voluntarily participated in the study and signed the informed consent form with good compliance.
Exclusion Criteria:
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Known history of drug or food allergy.
-
Known medical history judged by the investigator as not suitable for the study.
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Has laboratory or physical examination abnormalities during the screening period.
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Has a positive test for, HBV，HCV，HIV，or syphilis.
-
Has drug abuse history or positive drug abuse test results.
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Has diseases affecting the absorption, distribution, metabolism, and excretion of oral drugs.
-
Has any other conditions judged by the investigator as not suitable for the study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Shanghai Henlius Biotech
Investigators
- Principal Investigator: Liyan Miao, Dr., The First Affiliated Hospital of Soochow University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HLX208-PK-002