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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorShenyang Sunshine Pharmaceutical Co., LTD.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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 ."

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • [14C]SSS17

    Drug

    single oral dose

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: SSS17Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative excretion rate of radioactivity in excreta (urine, feces) and total radioactivity (urine and feces)

Time frame
up to Day 22
2

Cmax

Time frame
up to day22
3

Tmax

Time frame
up to Day22

Secondary outcomes

1

AEs

Time frame
up to day 22

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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