NCT05753033CompletedPhase 1
A Phase I Bridging Study to Evaluate the PK, Safety and Tolerability of SR750 in Healthy Subjects
Shanghai SIMR Biotechnology Co., Ltd.1 site in 1 country56 target enrollmentStarted: February 28, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Cmax
Study Overview
Brief Summary
This is a randomized, double-blind, placebo-controlled phase I PK bridging study to evaluate the PK, safety and tolerability of SR750 in healthy subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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 -
- •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
- •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.
Arms & Interventions
SR750 tablet
Experimental
Ascending single and multiple doses of SR750 orally
Intervention: SR750 tablet (Drug)
Placebo
Placebo Comparator
Ascending single and multiple doses of placebo orally
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Cmax
Time Frame: Up to Day 9
Peak plasma concentration
Tmax
Time Frame: Up to Day 9
Time of peak plasma concentration
t1/2
Time Frame: Up to Day 9
Terminal half-life
Rac
Time Frame: Up to Day 9
Accumulation ratio
AUC
Time Frame: Up to Day 9
Area under the plasma concentration-time curve
CL/F
Time Frame: Up to Day 9
Apparent oral clearance
Secondary Outcomes
- AE: Adverse Event(Up to Day14(+7 days) for the safety follow up since Day1)
Investigators
Study Sites (1)
Loading locations...
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