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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-17

Study Completion Date

2023-12-15

Brief Summary

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

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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.

Conditions

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Mass Balance Study in Healthy Subjects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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[14C]HLX208

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

Group Type EXPERIMENTAL

[14C]HLX208

Intervention Type DRUG

Carbon-14 labeled HLX208

Interventions

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[14C]HLX208

Carbon-14 labeled HLX208

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes