Healthy Subjects (HS)Phase 1NCT07025915
A Phase 1 Mass Balance Study of [¹⁴C]SSS17 in Healthy Chinese Males
A Phase 1 study testing [14C]SSS17 in people with Healthy Subjects (HS), run by Shenyang Sunshine Pharmaceutical Co., LTD..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects (HS)
- What is being tested?
- [14C]SSS17
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Jul 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 ."
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Mass Balance Study of [14C]SSS17 in Healthy Chinese Male Subjects
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)
- Being tested
- [14C]SSS17
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]SSS17Drug
single oral dose
| Study group | Role | What they receive |
|---|---|---|
| SSS17 | Experimental | Not described Receives: Drug: [14C]SSS17 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative excretion rate of radioactivity in excreta (urine, feces) and total radioactivity (urine and feces)
Measured: up to Day 22
Cmax
Measured: up to day22
Tmax
Measured: up to Day22
Secondary outcomes (1)
AEs
Measured: up to day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Subjects (HS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025915
- Sponsor's protocol ID
- SSS17-104
- Status last verified
- Jun 2025
- First submitted
- 6 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mass Balance Study of [14C]SSS17 in Healthy Chinese Male Subjects
- ClinicalTrials.gov ID
- NCT07025915
- Acronym / sponsor ID
- SSS17-104
- Conditions
- Healthy Subjects (HS)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SSS17 | Experimental | Drug: [14C]SSS17 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 ."
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]SSS17single oral dose | Drug | SSS17 |
Primary outcome
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
1 secondary outcome
AEs
Time frame: up to day 22
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]SSS17 in people with Healthy Subjects (HS), run by Shenyang Sunshine Pharmaceutical Co., LTD..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Professor miu (0512-67972861, sdfyec@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative excretion rate of radioactivity in excreta (urine, feces) and total radioactivity (urine and feces) (time frame: up to Day 22). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.