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

Phase 1

Not yet recruiting

• Conditions: Healthy Subjects (HS)
• Interventions: Drug: [14C]SSS17

• Registration Number: NCT07025915
• Lead Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted: 2025-06-06
• Study First Submitted QC: 2025-06-17
• Study First Posted: 2025-06-18
• Last Update Submitted: 2025-06-19
• Last Update Posted: 2025-06-25
• Primary Completion: 2025-07
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1. Healthy adult male subjects aged 18-45 years .
2. Body weight ≥50 kg .
3. Normal findings on comprehensive health assessment.
4. 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

1. 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.
2. History of organic heart disease
3. History of hypersensitivity or allergy to active ingredients.
4. Average daily smoking >5 cigarettes within 3 months prior to screening or inability to abstain during the trial.
5. Average weekly alcohol intake >14 units within 3 months prior to screening or positive alcohol breath test.
6. History of drug abuse or illicit drug use, or positive urine drug screen.
7. Participation in any other investigational drug trial within 3 months prior to screening.
8. Use of any prescription/non-prescription medication within 2 weeks prior to investigational product administration.
9. History of needle/phobia or inability to tolerate venipuncture.
10. Hemorrhoids/active perianal bleeding, chronic constipation/diarrhea or positive fecal occult blood test at screening.
11. Occupational radiation exposure;
12. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SSS17	[14C]SSS17	-

Primary Outcome Measures

Name	Time	Method
Cumulative excretion rate of radioactivity in excreta (urine, feces) and total radioactivity (urine and feces)	up to Day 22
Cmax	up to day22
Tmax	up to Day22

Secondary Outcome Measures

Name	Time	Method
AEs	up to day 22