Clinical trial NCT07025915: A Phase 1 Mass Balance Study of [¹⁴C]SSS17 in Healthy Chinese Males
Official title: A Mass Balance Study of [14C]SSS17 in Healthy Chinese Male Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Subjects (HS)
Lead sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.
Sponsor class: INDUSTRY
First posted: 2025-06-18
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims to evaluate the absorption, metabolism, and excretion (AME) 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.


Eligibility criteria: 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 (GCP)."

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. Positive result for any of: HIV antibody, HCV antibody, hepatitis B surface antigen , or Treponema pallidum-specific antibody .
3. History of organic heart disease
4. History of hypersensitivity or allergy to active ingredients.
5. Average daily smoking \>5 cigarettes within 3 months prior to screening or inability to abstain during the trial.
6. Average weekly alcohol intake \>14 units within 3 months prior to screening or positive alcohol breath test.
7. History of drug abuse or illicit drug use, or positive urine drug screen.
8. Participation in any other investigational drug trial within 3 months prior to screening.
9. Habitual consumption of alcohol, xanthine-containing products, or grapefruit that cannot be abstained from during the trial period, which may affect drug ADME.
10. Use of any prescription/non-prescription medication within 2 weeks prior to investigational product administration.
11. History of needle/phobia or inability to tolerate venipuncture.
12. Hemorrhoids/active perianal bleeding, chronic constipation/diarrhea, IBS, IBD, or positive fecal occult blood test at screening.
13. Occupational radiation exposure;
14. 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.

Primary outcomes:
measure: Cumulative excretion rate of radioactivity in excreta (urine, feces) and total radioactivity (urine and feces)
timeFrame: up to Day 22
measure: Cmax
timeFrame: up to day22
measure: Tmax
timeFrame: up to Day22
Secondary outcomes:
measure: AEs
timeFrame: up to day 22
Other outcomes:
Locations:
Study officials:
References: