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

Phase 1CompletedNCT05841940

Shanghai Henlius Biotech6 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Mass Balance Study in Healthy Subjects

Interventions

[14C]HLX208DRUG

Carbon-14 labeled HLX208

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Outcomes

Primary Outcomes

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

Time frame: Up to 336 hours post dose.

Total radioactivity in plasma PK: Cmax

Maximum plasma concentration