Mass Balance Study in Healthy Subjects
Conditions
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.
Interventions
DRUG[14C]HLX208
Carbon-14 labeled HLX208
Sponsors
Shanghai Henlius Biotech
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total radioactivity in plasma PK: Vz/F | Up to 240 hours post dose. | Apparent volume of distribution following oral administration. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| HLX208 and metabolite PK: Cmax | Up to 240 hours post dose. | Maximum plasma concentration |
Countries
China
Outcome results
None listed