Status:
COMPLETED
The Pharmacokinetics (PK), Safety, Tolerability of SR750 (Formulation F1) in Healthy Volunteers
Lead Sponsor:
Shanghai SIMR Biotechnology Co., Ltd.
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This is a randomized, double-blind, placebo-controlled phase I bridging study to evaluate the PK, safety and tolerability of SR750 (formulation F1) in Chinese healthy subjects.
Eligibility Criteria
Inclusion
- Healthy males and females who are 18 to 45 years of age.
- 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.
- Bodyweight of male \> 50 kg, Bodyweight of female \> 45 kg and body mass index (BMI) between 18 and28 kg/m2
- Male subjects must agree to use contraception methods.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion
- Known history of renal dysfunction or creatinine clearance \< 90 mL/min (calculated using the Cockcroft-Gault formula) at Screening.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities.
- 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.
- 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.
- 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.
- History of asthma (excluding resolved childhood asthma), severe allergic responses.
- History of hypercoagulable state or history of thrombosis.
- A positive Hepatitis B surface antigen, positive Hepatitis C antibody and positive test for human immunodeficiency virus (HIV) antibody.
- Within 6 months of screening, Smoking more than 4 cigarettes per day (including e-cigarettes).
- A positive drug/alcohol result at Screening or Day -1.
- 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.
- 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.
- 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.
- Female subjects with positive pregnancy test results.
- The investigator will determine any conditions in which subjects are not suitable for the study.
Key Trial Info
Start Date :
April 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06932536
Start Date
April 28 2025
End Date
July 7 2025
Last Update
December 31 2025
Active Locations (1)
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1
Shanghai Clinical Research Center Phase I Clinical Research Unit (SCRC-PCRU)
Shanghai, Shanghai Municipality, China