Healthy AdultsPhase 1NCT06204419
A Phase I Study of XH-S002 in Healthy Volunteers
A Phase 1 study testing XH-S002 （A） in people with Healthy Adults, run by S-INFINITY Pharmaceuticals Co., Ltd at 1 site in China.
Trial summary
The purpose of the study is to assess the safety, tolerability and pharmacokinetics of XH-S002 in healthy volunteers under SAD (Single ascending dose) and MAD (Multiple ascending dose) studies. In addition, this study evaluates the food effects of XH-S002. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- XH-S002 （A）
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2023to Oct 2024
- 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
- Male or Female healthy adult participants aged 18~45 years (inclusive);
- Male body weight is no less than 50 kilogram (Kg), Female body weight no less than 45 Kg, and body mass index (BMI) between 16.0 and 25.0 kg/m2 (both inclusive).
- Participants are in a good health and have no clinically significant abnormalities as per medical history, clinical symptoms, vital signs, physical examination, 12-lead ECG, chest X-ray, abdominal ultrasound and clinical laboratory tests (hematology, urinalysis, serum chemistry, coagulation function and fecal occult blood) results.
- After having a detailed understanding on the nature, significance, possible benefits, possible inconvenience and potential risks of this clinical trial, Participants would be able to take part in this clinical trial voluntarily, communicate well with investigator, abide by protocol procedures and sign written informed consent form (ICF).
- Participants promise no plan on fertility and donating sperm or ovum, and to take effective physical contraception (including female partner) from screening until one month after the end of the study.
Who cannot join
- Pregnant or lactating woman, or woman with a positive pregnancy test.
- Participants who are suspected or confirmed to be allergic to similar ingredient or any ingredients of investigational product, or participants who are allergic, or have a drug allergy history or specific allergic disorders (asthma, urticaria, eczema, etc.).
- Participants with a medical history or a current disorder of cardiovascular, pulmonary, endocrine, renal, hepatic, gastrointestinal, dermatology, immunology, hematology, neurology and psychiatric.
- Participants with clinically significant acute infection or concurrent severe infection (e.g., intravenous or oral antibiotics, anti-fungal or anti-viral drugs, etc.) or participant who has not recovered from infection within 2 weeks prior to screening.
- Participants who had a history of gastroesophageal reflux, dyspepsia, chronic nausea, or chronic diarrhea (≥3 stools per day, ≥4 weeks) within 6 months before screening.
Trial locations and contacts
1 site in 1 country.
Beijing Friendship Hospital, Capital Medical University contact
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality
Ruihua Dong, MD, 010-63139033, uihua_Dong_RW@163.com
About this study
Official title: A Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of XH-S002 After Single Ascending Doses, Multiple Ascending Doses and Evaluation of Food Effects in Healthy Volunteers
The purpose of the study is to assess the safety, tolerability and pharmacokinetics of XH-S002 in healthy volunteers under SAD (Single ascending dose) and MAD (Multiple ascending dose) studies. In addition, this study evaluates the food effects of XH-S002.
- Conditions
- Healthy Adults
- Being tested
- XH-S002 （A）, Placebo（B）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XH-S002 （A）Drug
XH-S002 powder will be administered orally as per assigned treatment regimen.
Placebo（B）Other
XH-S002 Placebo (matched) will be administered orally as per assigned treatment regimen.
| Study group | Role | What they receive |
|---|---|---|
| A (XH-S002) | Experimental | Participants will receive XH-S002 once or twice daily on scheduled days. Receives: Drug: XH-S002 （A） |
| B (Placebo) | Experimental | Participants will receive matching placebo once or twice daily on scheduled days. Receives: Other: Placebo（B） |
What is being measured
The primary outcome is the main question the study is designed to answer.
To access the safety and tolerability of single ascending dosed of XH-S002 in healthy adults.
Safety and tolerability of single dose of XH-S002 measured by number of subjects who experience AEs and potential clinically significant changes in clinical symptoms, vital signs, physical examinations, laboratory tests and ECG parameters.
Measured: Approximately 1～2weeks
To access the safety and tolerability of multiple ascending dosed of XH-S002 in healthy adults.
Safety and tolerability of multiple dose of XH-S002 measured by number of subjects who experience AEs and potential clinically significant changes in clinical symptoms, vital signs, physical examinations, laboratory tests and ECG parameters.
Measured: Approximately 1～2weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start26 Dec 2023
- Primary completionJul 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S-INFINITY Pharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204419
- Sponsor's protocol ID
- XH-S002-101
- Status last verified
- Dec 2023
- First submitted
- 18 Dec 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of XH-S002 After Single Ascending Doses, Multiple Ascending Doses and Evaluation of Food Effects in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06204419
- Acronym / sponsor ID
- XH-S002-101
- Conditions
- Healthy Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- S-INFINITY Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Dec 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 12 Jan 2024 (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.
The purpose of the study is to assess the safety, tolerability and pharmacokinetics of XH-S002 in healthy volunteers under SAD (Single ascending dose) and MAD (Multiple ascending dose) studies. In addition, this study evaluates the food effects of XH-S002.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A (XH-S002) | Experimental | Drug: XH-S002 （A）Participants will receive XH-S002 once or twice daily on scheduled days. |
| B (Placebo) | Experimental | Other: Placebo（B）Participants will receive matching placebo once or twice daily on scheduled days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or Female healthy adult participants aged 18~45 years (inclusive);
- Male body weight is no less than 50 kilogram (Kg), Female body weight no less than 45 Kg, and body mass index (BMI) between 16.0 and 25.0 kg/m2 (both inclusive).
- Participants are in a good health and have no clinically significant abnormalities as per medical history, clinical symptoms, vital signs, physical examination, 12-lead ECG, chest X-ray, abdominal ultrasound and clinical laboratory tests (hematology, urinalysis, serum chemistry, coagulation function and fecal occult blood) results.
- After having a detailed understanding on the nature, significance, possible benefits, possible inconvenience and potential risks of this clinical trial, Participants would be able to take part in this clinical trial voluntarily, communicate well with investigator, abide by protocol procedures and sign written informed consent form (ICF).
- Participants promise no plan on fertility and donating sperm or ovum, and to take effective physical contraception (including female partner) from screening until one month after the end of the study.
Key exclusion criteria (5 listed)
- Pregnant or lactating woman, or woman with a positive pregnancy test.
- Participants who are suspected or confirmed to be allergic to similar ingredient or any ingredients of investigational product, or participants who are allergic, or have a drug allergy history or specific allergic disorders (asthma, urticaria, eczema, etc.).
- Participants with a medical history or a current disorder of cardiovascular, pulmonary, endocrine, renal, hepatic, gastrointestinal, dermatology, immunology, hematology, neurology and psychiatric.
- Participants with clinically significant acute infection or concurrent severe infection (e.g., intravenous or oral antibiotics, anti-fungal or anti-viral drugs, etc.) or participant who has not recovered from infection within 2 weeks prior to screening.
- Participants who had a history of gastroesophageal reflux, dyspepsia, chronic nausea, or chronic diarrhea (≥3 stools per day, ≥4 weeks) within 6 months before 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 |
|---|---|---|
| XH-S002 （A）XH-S002 powder will be administered orally as per assigned treatment regimen. | Drug | A (XH-S002) |
| Placebo（B）XH-S002 Placebo (matched) will be administered orally as per assigned treatment regimen. | Other | B (Placebo) |
Primary outcome
To access the safety and tolerability of single ascending dosed of XH-S002 in healthy adults.
Time frame: Approximately 1～2weeks
Safety and tolerability of single dose of XH-S002 measured by number of subjects who experience AEs and potential clinically significant changes in clinical symptoms, vital signs, physical examinations, laboratory tests and ECG parameters.
To access the safety and tolerability of multiple ascending dosed of XH-S002 in healthy adults.
Time frame: Approximately 1～2weeks
Safety and tolerability of multiple dose of XH-S002 measured by number of subjects who experience AEs and potential clinically significant changes in clinical symptoms, vital signs, physical examinations, laboratory tests and ECG parameters.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Beijing Friendship Hospital, Capital Medical University contact
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 XH-S002 （A） in people with Healthy Adults, run by S-INFINITY Pharmaceuticals 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beijing Friendship Hospital, Capital Medical University, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To access the safety and tolerability of single ascending dosed of XH-S002 in healthy adults. (time frame: Approximately 1～2weeks). 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 12 Jan 2024.