Healthy Subjects (HS)Phase 1NCT07024888
A Study Evaluating the Food Effect on the Pharmacokinetics of SSS17 Capsules in Chinese Healthy Subjects
A Phase 1 study testing SSS17 in people with Healthy Subjects (HS), run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.
Trial summary
This study mainly compared the blood drug concentration and main pharmacokinetic parameters of SSS17 capsules taken orally once by healthy Chinese subjects under fasting conditions, 2 hours after administration, and when consuming a high-fat meal or a low-fat meal simultaneously. 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?
- SSS17
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2025to 28 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 subjects aged 18 to 45 years
- Good health status with no clinically significant medical history.
- Agreement to use effective contraception from signing ICF until 6 months after trial completion, with no reproductive plan.
- Voluntarily sign informed consent form (ICF), capable of protocol compliance and scheduled follow-up
Who cannot join
- Hypersensitivity to investigational drug/excipients.
- Dysphagia, GI disorders affecting absorption, or relevant surgery history .
- Intolerance to venipuncture or needle/blood phobia.
- Clinically significant disorders affecting drug ADME.
- Clinically significant abnormalities in vital signs/PE/labs/12-lead ECG/chest X-ray at screening.
- Family history of malignancy or major surgery within 3 months pre-screening.
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- Participation in other drug/device trials with investigational product use within 3 months.
- Blood donation/loss within 3 months.
- Special diets (pitaya/grapefruit products) or strenuous exercise within 7 days pre-dosing affecting ADME.
- Any medication use within 14 days pre-dosing.
- Regular alcohol >14 units/week within 3 months.
- Smoking >5 cigarettes/day within 3 months or unwilling to abstain during trial.
- Caffeine products within 48h pre-dosing.
- Alcohol consumption within 48h or positive alcohol screen.
- Positive serology for HBsAg, HCV Ab, HIV Ab, or syphilis.
- Pregnancy/lactation or unprotected sex
- Positive drug screen, drug abuse history, or drug use within 3 months.
- Any condition compromising safety/compliance, or investigator's judgment of unsuitability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Food on the Pharmacokinetics of SSS17 Capsules: A Study in Chinese Healthy Subjects
This study mainly compared the blood drug concentration and main pharmacokinetic parameters of SSS17 capsules taken orally once by healthy Chinese subjects under fasting conditions, 2 hours after administration, and when consuming a high-fat meal or a low-fat meal simultaneously. The study evaluated the impact of food on SSS17 capsules.
- Conditions
- Healthy Subjects (HS)
- Being tested
- SSS17
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSS17Drug
Single oral administration of SSS17
| Study group | Role | What they receive |
|---|---|---|
| Fasting Group | Other | Not described Receives: Drug: SSS17 |
| Low-fat Meal Concomitant Administration Group | Other | Not described Receives: Drug: SSS17 |
| High-fat Meal 2-Hour Post-dose Group | Other | Not described Receives: Drug: SSS17 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: Day1 to Day73
AUC
Measured: Day 1 to Day 73
Secondary outcomes (4)
Tmax
Measured: Day1 to Day73
t1/2
Measured: Day 1 to Day 73
CL/F
Measured: Day 1 to Day 73
AEs
Measured: up to Day 73
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start16 Mar 2025
- Primary completion28 May 2025
- Study completion28 May 2025
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.
- More trials run by Shenyang Sunshine Pharmaceutical Co., LTD.The sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
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
- NCT07024888
- Sponsor's protocol ID
- SSS17-103
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 18 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 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Food on the Pharmacokinetics of SSS17 Capsules: A Study in Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT07024888
- Acronym / sponsor ID
- SSS17-103
- Conditions
- Healthy Subjects (HS)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 16 Mar 2025 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 17 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 mainly compared the blood drug concentration and main pharmacokinetic parameters of SSS17 capsules taken orally once by healthy Chinese subjects under fasting conditions, 2 hours after administration, and when consuming a high-fat meal or a low-fat meal simultaneously. The study evaluated the impact of food on SSS17 capsules.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fasting Group | Other | Drug: SSS17 |
| Low-fat Meal Concomitant Administration Group | Other | Drug: SSS17 |
| High-fat Meal 2-Hour Post-dose Group | Other | Drug: SSS17 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult subjects aged 18 to 45 years
- Good health status with no clinically significant medical history.
- Agreement to use effective contraception from signing ICF until 6 months after trial completion, with no reproductive plan.
- Voluntarily sign informed consent form (ICF), capable of protocol compliance and scheduled follow-up
Key exclusion criteria (18 listed)
- Hypersensitivity to investigational drug/excipients.
- Dysphagia, GI disorders affecting absorption, or relevant surgery history .
- Intolerance to venipuncture or needle/blood phobia.
- Clinically significant disorders affecting drug ADME.
- Clinically significant abnormalities in vital signs/PE/labs/12-lead ECG/chest X-ray at screening.
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 |
|---|---|---|
| SSS17Single oral administration of SSS17 | Drug | Fasting Group, High-fat Meal 2-Hour Post-dose Group, Low-fat Meal Concomitant Administration Group |
Primary outcome
Cmax
Time frame: Day1 to Day73
AUC
Time frame: Day 1 to Day 73
4 secondary outcomes
Tmax
Time frame: Day1 to Day73
t1/2
Time frame: Day 1 to Day 73
CL/F
Time frame: Day 1 to Day 73
AEs
Time frame: up to Day 73
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SSS17 in people with Healthy Subjects (HS), run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.
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 18 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: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Day1 to Day73). The study lists 2 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 18 Jun 2025.