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

Henlius Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Mass Balance Study in Healthy Subjects

Treatments: Drug: [14C]HLX208

Study type: Interventional

Funder types: Industry

Identifiers

NCT05841940

HLX208-PK-002

Details and patient eligibility

About

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

Full description

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

Enrollment: 6 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

[14C]HLX208

Experimental group

Description:

Single oral dose of 450mg \[14C\]HLX208 suspension.

Treatment:

Drug: [14C]HLX208