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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05946876




Registration number
NCT05946876
Ethics application status
Date submitted
7/07/2023
Date registered
14/07/2023
Date last updated
18/01/2024

Titles & IDs
Public title
A Phase 1 Study of XH-S003 in Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
XH-S003-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - XH-S003 (A)
Other interventions - Placebo (B)

Experimental: A (XH-S003) - Participants will receive an oral dose of XH-S003 once daily on scheduled day(s).
Dosage: Part A : 50mg,100mg, 200mg, 25mg & 400mg Part B : 25mg, 50mg, 100mg. Part C : 200 mg

Placebo Comparator: B (Placebo) - Participants will receive oral matching placebo once daily on scheduled day(s)


Treatment: Drugs: XH-S003 (A)
IP: XH-S003 IP: XH-S003 Dose: 25 mg, 100 mg Dose Formulation: Capsule Route of Administration: Oral

Other interventions: Placebo (B)
Dose: 25 mg, 100 mg Dose Formulation: Capsule Route of Administration: Oral
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events (AEs)
Timepoint [1] 0 0
Part A: Upto 10 days
Primary outcome [2] 0 0
Number of participants with adverse events (AEs)
Timepoint [2] 0 0
Part B: Up to 28 days
Primary outcome [3] 0 0
Number of participants with adverse events (AEs)
Timepoint [3] 0 0
Part C: Up to 7 days
Primary outcome [4] 0 0
Number of participants with clinical laboratory abnormalities
Timepoint [4] 0 0
Part A: Upto 10 days
Primary outcome [5] 0 0
Number of participants with clinical laboratory abnormalities
Timepoint [5] 0 0
Part B: Up to 28 days
Primary outcome [6] 0 0
Number of participants with clinical laboratory abnormalities
Timepoint [6] 0 0
Part C: Up to 7 days

Eligibility
Key inclusion criteria
1. Male or female, aged = 18 to = 55 years old.

2. 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.

3. Able and willing to comply with the study procedure and the restriction specified in
the protocol.

4. Provision of signed and dated written informed consent prior to any study specific
procedures.

5. 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).

- 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.

6. 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.

7. Subjects do not plan to donate sperm or eggs from the time of signing the informed
consent until 3 months after EOS/ET.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. 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.

2. 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).

3. 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.

4. 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.

5. 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.

6. Known or suspected immunodeficiency, hereditary or acquired complement deficiency.

7. 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).

8. 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.

9. Donated more than 400 mL of blood within 90 days or donated plasma within 14 days
before screening.

10. Subjects who received blood product transfusion within 90 days before screening.

11. 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.

12. Subjects positive for drug abuse test or with a history of drug abuse at screening.
One repeat test on the same day is permitted.

13. 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.

14. 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.

15. 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.

16. Subjects who are unable to avoid strenuous exercise during confinement.

17. 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.

18. Subjects who are not suitable for venous blood collection.

19. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/08/2024
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
S-Infinity Pharmaceuticals Co., Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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. In addition, this study evaluates the effects
of food on XH-S003 under a two-period, cross-over study setting.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05946876
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jing Lv
Address 0 0
Country 0 0
Phone 0 0
+86-13844017143
Fax 0 0
Email 0 0
lvjing2@fosunpharma.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05946876