Human Mass Balance Study of HMS5552 in Healthy Subjects

An Open-Label, Single Center Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Oral Dose of 50 mg (90 uCi) [14C]-HMS5552 in Healthy Adult Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03158506

Enrollment

Registered

2017-05-18

Start date

2017-03-29

Completion date

2017-04-06

Last updated

2018-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subject

Brief summary

This is an open-label, single center, 1-period study in healthy adult male subjects to assess absorption, metabolism, and excretion of HMS5552 after a single oral administration of 50 mg (90 μCi) of \[14C\]-HMS5552.

Interventions

DRUGHMS5552

\[14C\]-labelled HMS5552

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy, adult, male 19-55 years of age * Weight at least 50 kg, and BMI within the range of 18-30 kg/m2 * Written informed consent must be obtained before any assessment is performed

Exclusion criteria

* History or presence of clinically significant medical, surgical or psychiatric condition or disease in the opinion of the Investigator or designee which might significantly alter the absorption, distribution, metabolism and excretion of drugs. * History or presence of alcoholism or drug abuse. * Smoker. * Abnormal bowel habits.

Design outcomes

Primary

Measure	Time frame	Description
Total radioactivity in blood, plasma urine and feces	Up to 168 hours	Peak plasma concentration (Cmax)

Secondary

Measure	Time frame	Description
Concentrations of HMS5552 and its metabolites in plasma, urine and feces	Up to 168 hours	Peak plasma concentration (Cmax)
Number of participants with adverse events as a measure of safety and tolerability	Up to 168 hours	Adverse events; Laboratory parameters; Vital signs, clinical signs and symptoms and physical examination, including changes from baseline; ECG evaluation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026