The Pharmacokinetics (PK), Safety, Tolerability of SR750 (Formulation F1) in Healthy Volunteers
NCT ID: NCT06932536
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2025-04-28
2025-07-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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SR750 tablet
Ascending single (30-100 mg) and multiple (30-60 mg twice daily \[b.i.d.\]) doses of SR750 orally
SR750 tablet
Ascending single (30-100 mg) and multiple (30-60 mg twice daily \[b.i.d.\]) doses of SR750 orally
Placebo
Ascending single and multiple doses of placebo orally
Placebo
Ascending single and multiple doses of placebo orally
Interventions
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SR750 tablet
Ascending single (30-100 mg) and multiple (30-60 mg twice daily \[b.i.d.\]) doses of SR750 orally
Placebo
Ascending single and multiple doses of placebo orally
Eligibility Criteria
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Inclusion Criteria
2. Based on medical history, physical examination, laboratory examination, chest X-ray, abdominal B-ultrasound, vital signs and ECG, the investigator considered that the results were normal or abnormal but no clinical significance.
3. Bodyweight of male \> 50 kg, Bodyweight of female \> 45 kg and body mass index (BMI) between 18 and28 kg/m2
4. Male subjects must agree to use contraception methods.
5. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion Criteria
2. Current or chronic history of liver disease or known hepatic or biliary abnormalities.
3. History of regular alcohol consumption within 6 months of screening defined as: an average weekly intake of \>21 units for males or \>14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (\~285 mL) of beer, 1 glass (125 mL) of wine or 1 measure (25 mL) of spirits.
4. History of significant drug abuse within one year of screening or use of soft drugs (such as marijuana) within 3 months prior to screening or hard drugs (such as cocaine, methamphetamine, crack) within 1 year prior to screening.
5. History of sensitivity to any of the investigational medicinal products (IMPs), or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation.
6. History of asthma (excluding resolved childhood asthma), severe allergic responses.
7. History of hypercoagulable state or history of thrombosis.
8. A positive Hepatitis B surface antigen, positive Hepatitis C antibody and positive test for human immunodeficiency virus (HIV) antibody.
9. Within 6 months of screening, Smoking more than 4 cigarettes per day (including e-cigarettes).
10. A positive drug/alcohol result at Screening or Day -1.
11. Donation or lost in excess of 500 mL of blood within 56 days of Day 1 or donation of plasma within 14 days of Day 1.
12. The subject has participated in a clinical trial within 3 months of receiving IMP.
Use of medication other than topical products without significant systemic absorption.
13. Unable to refrain from consumption of Seville oranges, grapefruit or grapefruit juice within 24h prior to the first dose of IMP until the Safety Follow-up visit.
14. Female subjects with positive pregnancy test results.
15. The investigator will determine any conditions in which subjects are not suitable for the study.
18 Years
45 Years
ALL
Yes
Sponsors
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Shanghai SIMR Biotechnology Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Qian Chen
Role: PRINCIPAL_INVESTIGATOR
Shanghai Clinical Research Center Phase I Clinical Research Unit (SCRC-PCRU)
Locations
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Shanghai Clinical Research Center Phase I Clinical Research Unit (SCRC-PCRU)
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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SR750-103
Identifier Type: -
Identifier Source: org_study_id