A Phase 1 Mass Balance Study of [¹⁴C]SSS17 in Healthy Chinese Males
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [14C]SSS17.
- Who it may be relevant to
- Registry conditions: Healthy Subjects (HS). Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Mass Balance Study of [14C]SSS17 in Healthy Chinese Male Subjects
Overview
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.
Interventions
- Drug [14C]SSS17
single oral dose
Primary outcome measures
- Cumulative excretion rate of radioactivity in excreta (urine, feces) and total radioactivity (urine and feces) [Time frame: up to Day 22]
- Cmax [Time frame: up to day22]
- Tmax [Time frame: up to Day22]
Secondary outcome measures (1)
- AEs [Time frame: up to day 22]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07025915 · SSS17-104