Not Yet RecruitingPhase 1

A Phase 1 Mass Balance Study of [¹⁴C]SSS17 in Healthy Chinese Males

6 participantsStarted 2025-06

Plain-language summary

This study aims to evaluate the absorption, metabolism, and excretion of a single oral dose of \[¹⁴C\]SSS17 in healthy adult Chinese male subjects, elucidating its overall pharmacokinetic profile in humans to provide essential information for its rational clinical use.

Who can participate

Age range18 Years – 45 Years

SexALL

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Inclusion criteria

✓. Healthy adult male subjects aged 18-45 years .
✓. Body weight ≥50 kg .
✓. Normal findings on comprehensive health assessment.
✓. The subject demonstrates understanding of the trial's objectives, requirements, procedures, and potential adverse reactions; voluntarily participates; commits to complete all trial activities per protocol and comply with study regulations; with the informed consent process conducted in compliance with Good Clinical Practice ."

Exclusion criteria

✕. Subjects with abnormalities in the nervous system, respiratory system, cardiovascular system, digestive system, hematological and lymphatic systems, endocrine system, or musculoskeletal system that are deemed clinically significant by the investigator.
✕. History of organic heart disease
✕. History of hypersensitivity or allergy to active ingredients.
✕. Average daily smoking \>5 cigarettes within 3 months prior to screening or inability to abstain during the trial.
✕. Average weekly alcohol intake \>14 units within 3 months prior to screening or positive alcohol breath test.
✕. History of drug abuse or illicit drug use, or positive urine drug screen.
✕. Participation in any other investigational drug trial within 3 months prior to screening.
✕. Use of any prescription/non-prescription medication within 2 weeks prior to investigational product administration.

What they're measuring

Cumulative excretion rate of radioactivity in excreta (urine, feces) and total radioactivity (urine and feces)

Timeframe: up to Day 22

Cmax

Timeframe: up to day22

Tmax

Timeframe: up to Day22

Trial details

NCT IDNCT07025915

SponsorShenyang Sunshine Pharmaceutical Co., LTD.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07

Contact for this trial

Professor miu

0512-67972861 sdfyec@163.com

View on ClinicalTrials.gov More Healthy Subjects (HS) trials