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

Shenyang Sunshine Pharmaceutical

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Subjects (HS)

Treatments: Drug: [14C]SSS17

Study type: Interventional

Funder types: Industry

Identifiers

NCT07025915

SSS17-104

Details and patient eligibility

About

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.

Enrollment: 6 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

SSS17

Experimental group

Treatment:

Drug: [14C]SSS17