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

NCT07025915 | Not Yet Recruiting Phase 1

• 1 other identifier: SSS17-104
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Subjects (HS)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• AEs

  up to day 22

Study Arms (1)

SSS17

EXPERIMENTAL

Drug: [14C]SSS17

Interventions

[14C]SSS17 DRUG

single oral dose

SSS17

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 ."

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenyang Sunshine Pharmaceutical Co., LTD.: lead

Central Study Contacts

Professor miu

CONTACT

0512-67972861; sdfyec@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 18, 2025
• Study Start: June 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06