Healthy
Conditions
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.
Interventions
DRUGSR750 tablet
Ascending single (30-100 mg) and multiple (30-60 mg twice daily \[b.i.d.\]) doses of SR750 orally
DRUGPlacebo
Ascending single and multiple doses of placebo orally
Sponsors
Shanghai SIMR Biotechnology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy males and females who are 18 to 45 years of age. 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
1. Known history of renal dysfunction or creatinine clearance \< 90 mL/min (calculated using the Cockcroft-Gault formula) at Screening. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC | Up to 48 hours post-dose | Area under the plasma concentration-time curve |
| Cmax | Up to 48 hours post-dose | Peak plasma concentration |
| Tmax | Up to 48 hours post-dose | Time of peak plasma concentration |
| Rac | Up to 48 hours post-dose | Accumulation ratio |
| CL/F | Up to 48 hours post-dose | Apparent oral clearance |
| t1/2 | Up to 48 hours post-dose | Terminal half-life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AE: Adverse Event | Up to Day 7(+ 7 days) for the safety follow up post-dose | The frequency and severity of althy volunteers administrated with single and repeated oral doses of SR750 AEs |
Countries
China
Outcome results
None listed