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NCT Number: NCT07025915

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • History of needle/phobia or inability to tolerate venipuncture.
  • Hemorrhoids/active perianal bleeding, chronic constipation/diarrhea or positive fecal occult blood test at screening.
  • Occupational radiation exposure;
  • Pregnancy plans during or within 1 year post-trial, or refusal to use strict contraception by subject/partner during and within 1 year post-trial.

Treatment and study plan

[14C]SSS17

Drug

single oral dose

Primary outcomes

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

    Time frame: up to Day 22

  2. Cmax

    Time frame: up to day22

  3. Tmax

    Time frame: up to Day22

Secondary outcomes

  1. AEs

    Time frame: up to day 22

Study contacts

Contact information is provided by the study sponsor or research team.

Professor miu

CONTACT

[email protected]

0512-67972861

Sponsors and collaborators

Lead sponsor

Shenyang Sunshine Pharmaceutical Co., LTD.

Industry

Registry information

Official study title

A Mass Balance Study of [14C]SSS17 in Healthy Chinese Male Subjects

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 18, 2025
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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