Clinical trial NCT05841940: Mass Balance Study of [14C]HLX208 in China Healthy Subjects
Official title: Mass Balance Study of [14C]HLX208 in China Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mass Balance Study in Healthy Subjects
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2023-05-03
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mass balance recovery of total radioactivity in urine and fecal samples.
timeFrame: Up to 336 hours post dose.
measure: Total radioactivity in plasma PK: Cmax
timeFrame: Up to 240 hours post dose.
measure: Total radioactivity in plasma PK: Tmax
timeFrame: Up to 240 hours post dose.
measure: Total radioactivity in plasma PK: AUC0-t
timeFrame: Up to 240 hours post dose.
measure: Total radioactivity in plasma PK: AUC0-∞
timeFrame: Up to 240 hours post dose.
measure: Total rradioactivity in plasma PK: t1/2
timeFrame: Up to 240 hours post dose.
measure: Total radioactivity in plasma PK: CL/F
timeFrame: Up to 240 hours post dose.
measure: Total radioactivity in plasma PK: Vz/F
timeFrame: Up to 240 hours post dose.
Secondary outcomes:
measure: HLX208 and metabolite PK: Cmax
timeFrame: Up to 240 hours post dose.
measure: HLX208 and metabolite PK: Tmax
timeFrame: Up to 240 hours post dose.
measure: HLX208 and metabolite PK: AUC0-t
timeFrame: Up to 240 hours post dose.
measure: HLX208 and metabolite PK: AUC0-∞
timeFrame: Up to 240 hours post dose.
measure: HLX208 and metabolite PK: t1/2
timeFrame: Up to 240 hours post dose.
measure: Adverse events
timeFrame: Screening up to Day 15
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Liyan Miao, Dr.
role: PRINCIPAL_INVESTIGATOR
References: