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

Study Overview
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Brief Summary
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Mass Balance Study of [14C]HLX208 in China Healthy Subjects.

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

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

Conditions
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Mass Balance Study in Healthy Subjects

Intervention / Treatment
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* Drug: [14C]HLX208


Participation Criteria
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Eligibility Criteria
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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. 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: Known history of drug or food allergy. Known medical history judged by the investigator as not suitable for the study. Has laboratory or physical examination abnormalities during the screening period. Has a positive test for, HBV，HCV，HIV，or syphilis. Has drug abuse history or positive drug abuse test results. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [14C]HLX208<br>Single oral dose of 450mg [14C]HLX208 suspension. | Drug: [14C]HLX208<br>* Carbon-14 labeled HLX208<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mass balance recovery of total radioactivity in urine and fecal samples. | Mass balance recovery of total radioactivity in urine and fecal samples. | Up to 336 hours post dose. | 
| Total radioactivity in plasma PK: Cmax | Maximum plasma concentration | Up to 240 hours post dose. | 
| Total radioactivity in plasma PK: Tmax | Time for Cmax | Up to 240 hours post dose. | 
| Total radioactivity in plasma PK: AUC0-t | Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration. | Up to 240 hours post dose. | 
| Total radioactivity in plasma PK: AUC0-∞ | Area under the plasma concentration time profile from time 0 to infinity. | Up to 240 hours post dose. | 
| Total rradioactivity in plasma PK: t1/2 | Elimination half-life. | Up to 240 hours post dose. | 
| Total radioactivity in plasma PK: CL/F | Drug clearance. | Up to 240 hours post dose. | 
| Total radioactivity in plasma PK: Vz/F | Apparent volume of distribution following oral administration. | Up to 240 hours post dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HLX208 and metabolite PK: Cmax | Maximum plasma concentration | Up to 240 hours post dose. | 
| HLX208 and metabolite PK: Tmax | Time for Cmax | Up to 240 hours post dose. | 
| HLX208 and metabolite PK: AUC0-t | Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration. | Up to 240 hours post dose. | 
| HLX208 and metabolite PK: AUC0-∞ | Area under the plasma concentration time profile from time 0 to infinity. | Up to 240 hours post dose. | 
| HLX208 and metabolite PK: t1/2 | Elimination half-life. | Up to 240 hours post dose. | 
| Adverse events | Number of adverse events, which are any untoward medical occurrence regardless of attribution to study drug in a participant who received study drug. | Screening up to Day 15 |