HealthyPhase 1NCT05946876
A Phase 1 Study of XH-S003 in Healthy Volunteers
A Phase 1 study testing XH-S003 (A) in people with Healthy, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 1 site in Australia.
Trial summary
This is a phase 1, randomised, first-in-human, double-blinded, placebo-controlled, SAD (Single Ascending Dose) and MAD (Multiple Ascending Dose) study to assess the PK, safety, and tolerability of XH-S003 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- XH-S003 (A)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteAustralia
- Study dates
- 24 Aug 2023to 14 Aug 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, aged ≥ 18 to ≤ 55 years old.
- BMI between ≥ 19.0 and ≤ 30.0 kg/m2 at Screening, and weight between ≥ 50 kg and ≤ 120.0kg for male, weight ≥ 45 kg and ≤ 120.0kg for female.
- Able and willing to comply with the study procedure and the restriction specified in the protocol.
- Provision of signed and dated written informed consent prior to any study specific procedures.
- Female subjects of childbearing potential must have a negative serum pregnancy test result at screening and a negative pregnancy test result at baseline, and agree to use one of the acceptable methods of contraception listed below during the study (from the time of signing the informed consent until one month after the end of study [EOS] or early termination visit evaluation [ET]):
- The subject's male partner has undergone documented vasectomy with documentation of azoospermia (male sterilization).
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- A documented placement of an intrauterine device (IUD) or intrauterine system (IUS).
- Consistent use of the same oral contraceptives for at least 3 months before screening, injectable progesterone, subdermal implants, or the use of a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps], which present no effect on IP at the discretion of investigator).
- Documented tubal ligation (female sterilization).
- True abstinence: when this is in line with the preferred and usual lifestyle of the subject, including female subjects with same sex partners. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Abstinent subjects must agree to use one of the above-mentioned contraceptive methods, if they start sexual relationships during the study.
- Male subjects agreeing to use acceptable methods of contraception if the male subject's partner could become pregnant from the time of signing the informed consent until 3 months after EOS/ET. One of the following acceptable methods of contraception must be utilized:
- Surgical sterilization (vasectomy with documentation of azoospermia).
- The subject's female partner uses oral contraceptives (including combination estrogen/progesterone pills, progesterone pills), injectable progesterone, or subdermal implants, or a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps]).
- The subject's female partner uses medically prescribed topically applied transdermal contraceptive patch.
- The subject's female partner has undergone documented tubal ligation (female sterilization).
- The subject's female partner has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS).
- True abstinence: when this is in line with the preferred and usual lifestyle of the subject, including male subjects with same sex partners. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Abstinent subjects must agree to use one of the above-mentioned contraceptive methods, if they start sexual relationships during the study.
- Subjects do not plan to donate sperm or eggs from the time of signing the informed consent until 3 months after EOS/ET.
Who cannot join
- Subjects with a history of allergies to similar ingredients of the study drug or any ingredient in the study drug, or vaccine component; subjects with a history of severe allergic or anaphylactic reactions at the discretion of PI. Subjects with one of the conditions (including, but not limited to):
- Subjects with history of eczema within 3 years.
- Subjects with asthma except for resolved childhood asthma.
- Subjects with clinical syndromes of urticaria at screening or baseline.
- Subjects whose abnormalities in past medical history are clinically significant or other clinical findings suggest the following clinically significant diseases at the discretion of the PI (including but not limited to gastrointestinal, renal, hepatic, neurological, hematologic, endocrine, pulmonary, psychiatric, or cardiovascular and cerebrovascular diseases, which are deemed as clinically significant by PI).
- Abnormal liver function tests at screening, defined as alanine aminotransferase (ALT) or aspartate transaminase (AST) > 1.5x upper limit of normal (ULN), and bilirubin >1.5x ULN (isolated bilirubin > 1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%) that are considered by the PI to be clinically significant. Repeat tests are permitted at investigator discretion.
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- Abnormal ECG findings at Screening or Day -1 (eg, repeated demonstration of a QTc interval > 450 ms [male] or > 470 ms [female] corrected by Fridericia's formula [QTcF] or Bazett's formula [QTcB]; heart rate [HR] is out of normal range 45-100 bmp; PR is out of normal range 120 -220 msec; QRS is out of normal range <120msec) that are considered by the PI or designee to be clinically significant. Repeat tests are permitted at investigator discretion.
- Subjects with clinically significant infection (e.g., requiring hospitalization or parenteral antimicrobial therapy) within 2 months before screening or active systemic bacterial, viral, or fungal infection or fever with ear temperature > 37.7℃ within 2 weeks before screening at the discretion of the PI.
- Known or suspected immunodeficiency, hereditary or acquired complement deficiency.
- Clinical laboratory evidence or clinical diagnosis of human immunodeficiency virus (HIV) infection, hepatitis C virus (HCV) infection, or chronic hepatitis B virus (HBV) infection (as shown by hepatitis B surface antigen [HBsAg] positivity).
- Subjects who had major injuries or underwent major surgery or had not recovered from surgery or had the surgery affecting the drug metabolic process and safety assessment within 6 months prior to screening, or who are scheduled to undergo surgery during the study period.
- Donated more than 400 mL of blood within 90 days or donated plasma within 14 days before screening.
- Subjects who received blood product transfusion within 90 days before screening.
- Used any medications (including but not limited to prescription medication, over-the-counter medication, herb, etc. [except for contraceptive use]) within 14 days or 7 half-lives (whichever is longer) of administration of the first dose of investigational product.
- Subjects positive for drug abuse test or with a history of drug abuse at screening. One repeat test on the same day is permitted.
- Subjects with a history of alcohol abuse within 1 month prior to screening (average consuming 14 units or more of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 125 mL of wine) or positive for alcohol breath test (one repeat test on the same day is permitted) at screening.
- Subjects who smoked more than 5 cigarettes every day within 1 month prior to screening or who are not willing to quit smoking during the confinement.
- Subjects who consume food or beverage containing grapefruit/pomelo or alcohol/caffeine (e.g., coffee, chocolate, cola, tea, etc.) within 48 hours prior to confinement and during the confinement.
- Subjects who are unable to avoid strenuous exercise during confinement.
- Subjects who have participated in other drug clinical trials within 3 months prior to screening or plan to participate in other clinical trial from enrolment to EOS/ET.
- Subjects who are not suitable for venous blood collection.
- Any other conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrolment or could interfere with the subject's participation in or completion of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics of XH-S003 After Single and Multiple Ascending Doses, Plus the Evaluation of Food Effects in Healthy Volunteers
This is a phase 1, randomised, first-in-human, double-blinded, placebo-controlled, SAD (Single Ascending Dose) and MAD (Multiple Ascending Dose) study to assess the PK, safety, and tolerability of XH-S003 in healthy volunteers. In addition, this study evaluates the effects of food on XH-S003 under a two-period, cross-over study setting.
Read the detailed description
The study is composed of three parts. Part A (SAD portion, 6 cohorts) and Part B (MAD portion, 3 cohorts) of the study will enrol eligible participants and provide various doses of XH-S003 or placebo at a ratio of 3:1 in each cohort. Part C of the study plans to evaluate the food effect on XH-S003.
- Conditions
- Healthy
- Being tested
- XH-S003 (A), Placebo (B)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XH-S003 (A)Drug
IP: XH-S003 IP: XH-S003 Dose: 25 mg, 100 mg Dose Formulation: Capsule Route of Administration: Oral
Placebo (B)Other
Dose: 25 mg, 100 mg Dose Formulation: Capsule Route of Administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| A (XH-S003) | Experimental | Participants will receive an oral dose of XH-S003 once daily on scheduled day(s).
Dosage: Part A : 50mg,100mg, 200mg, 25mg 、600mg 1000mg Part B : 25mg, 50mg, 150mg. Part C : 200 mg Receives: Drug: XH-S003 (A) |
| B (Placebo) | Placebo comparator | Participants will receive oral matching placebo once daily on scheduled day(s) Receives: Other: Placebo (B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
AEs assessed based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Part A: Upto 10 days
Number of participants with adverse events (AEs)
AEs assessed based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Part B: Up to 28 days
Number of participants with adverse events (AEs)
AEs assessed based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Part C: Up to 7 days
Number of participants with clinical laboratory abnormalities
Measured: Part A: Upto 10 days
Number of participants with clinical laboratory abnormalities
Measured: Part B: Up to 28 days
Number of participants with clinical laboratory abnormalities
Measured: Part C: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start24 Aug 2023
- Primary completion11 Jul 2024
- Study completion14 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Shanghai Fosun Pharmaceutical Industrial Development 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946876
- Sponsor's protocol ID
- XH-S003-101
- Status last verified
- Nov 2024
- First submitted
- 7 Jul 2023
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics of XH-S003 After Single and Multiple Ascending Doses, Plus the Evaluation of Food Effects in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05946876
- Acronym / sponsor ID
- XH-S003-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- 11 Jul 2024 (actual)
- Study completion
- 14 Aug 2024 (actual)
- First posted
- 14 Jul 2023 (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 is a phase 1, randomised, first-in-human, double-blinded, placebo-controlled, SAD (Single Ascending Dose) and MAD (Multiple Ascending Dose) study to assess the PK, safety, and tolerability of XH-S003 in healthy volunteers. In addition, this study evaluates the effects of food on XH-S003 under a two-period, cross-over study setting.
Detailed description
The study is composed of three parts. Part A (SAD portion, 6 cohorts) and Part B (MAD portion, 3 cohorts) of the study will enrol eligible participants and provide various doses of XH-S003 or placebo at a ratio of 3:1 in each cohort. Part C of the study plans to evaluate the food effect on XH-S003.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A (XH-S003) | Experimental | Drug: XH-S003 (A)Participants will receive an oral dose of XH-S003 once daily on scheduled day(s). Dosage: Part A : 50mg,100mg, 200mg, 25mg 、600mg 1000mg Part B : 25mg, 50mg, 150mg. Part C : 200 mg |
| B (Placebo) | Placebo comparator | Other: Placebo (B)Participants will receive oral matching placebo once daily on scheduled day(s) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Male or female, aged ≥ 18 to ≤ 55 years old.
- BMI between ≥ 19.0 and ≤ 30.0 kg/m2 at Screening, and weight between ≥ 50 kg and ≤ 120.0kg for male, weight ≥ 45 kg and ≤ 120.0kg for female.
- Able and willing to comply with the study procedure and the restriction specified in the protocol.
- Provision of signed and dated written informed consent prior to any study specific procedures.
- Female subjects of childbearing potential must have a negative serum pregnancy test result at screening and a negative pregnancy test result at baseline, and agree to use one of the acceptable methods of contraception listed below during the study (from the time of signing the informed consent until one month after the end of study [EOS] or early termination visit evaluation [ET]):
Key exclusion criteria (22 listed)
- Subjects with a history of allergies to similar ingredients of the study drug or any ingredient in the study drug, or vaccine component; subjects with a history of severe allergic or anaphylactic reactions at the discretion of PI. Subjects with one of the conditions (including, but not limited to):
- Subjects whose abnormalities in past medical history are clinically significant or other clinical findings suggest the following clinically significant diseases at the discretion of the PI (including but not limited to gastrointestinal, renal, hepatic, neurological, hematologic, endocrine, pulmonary, psychiatric, or cardiovascular and cerebrovascular diseases, which are deemed as clinically significant by PI).
- Abnormal liver function tests at screening, defined as alanine aminotransferase (ALT) or aspartate transaminase (AST) > 1.5x upper limit of normal (ULN), and bilirubin >1.5x ULN (isolated bilirubin > 1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%) that are considered by the PI to be clinically significant. Repeat tests are permitted at investigator discretion.
- Abnormal ECG findings at Screening or Day -1 (eg, repeated demonstration of a QTc interval > 450 ms [male] or > 470 ms [female] corrected by Fridericia's formula [QTcF] or Bazett's formula [QTcB]; heart rate [HR] is out of normal range 45-100 bmp; PR is out of normal range 120 -220 msec; QRS is out of normal range <120msec) that are considered by the PI or designee to be clinically significant. Repeat tests are permitted at investigator discretion.
- Subjects with clinically significant infection (e.g., requiring hospitalization or parenteral antimicrobial therapy) within 2 months before screening or active systemic bacterial, viral, or fungal infection or fever with ear temperature > 37.7℃ within 2 weeks before screening at the discretion of the PI.
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-S003 (A)IP: XH-S003 IP: XH-S003 Dose: 25 mg, 100 mg Dose Formulation: Capsule Route of Administration: Oral | Drug | A (XH-S003) |
| Placebo (B)Dose: 25 mg, 100 mg Dose Formulation: Capsule Route of Administration: Oral | Other | B (Placebo) |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Part A: Upto 10 days
AEs assessed based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Number of participants with adverse events (AEs)
Time frame: Part B: Up to 28 days
AEs assessed based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Number of participants with adverse events (AEs)
Time frame: Part C: Up to 7 days
AEs assessed based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Number of participants with clinical laboratory abnormalities
Time frame: Part A: Upto 10 days
Number of participants with clinical laboratory abnormalities
Time frame: Part B: Up to 28 days
Number of participants with clinical laboratory abnormalities
Time frame: Part C: Up to 7 days
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 25 Sep 2026.
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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 XH-S003 (A) in people with Healthy, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 1 site in Australia.
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 18 inclusion and 22 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 25 Sep 2026. 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 Australia. 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. Some participants in this study may receive a placebo. 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?
Number of participants with adverse events (AEs) (time frame: Part A: Upto 10 days). The study lists 6 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 Sep 2026.