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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SR750 tablet | Experimental | Ascending single (30-100 mg) and multiple (30-60 mg twice daily [b.i.d.]) doses of SR750 orally |
|
| Placebo | Placebo Comparator | Ascending single and multiple doses of placebo orally |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SR750 tablet | Drug | Ascending single (30-100 mg) and multiple (30-60 mg twice daily [b.i.d.]) doses of SR750 orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Peak plasma concentration | Up to 48 hours post-dose |
| Tmax | Time of peak plasma concentration | Up to 48 hours post-dose |
| AUC | Area under the plasma concentration-time curve | Up to 48 hours post-dose |
| CL/F | Apparent oral clearance | Up to 48 hours post-dose |
| t1/2 | Terminal half-life | Up to 48 hours post-dose |
| Rac | Accumulation ratio | Up to 48 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| AE: Adverse Event | The frequency and severity of althy volunteers administrated with single and repeated oral doses of SR750 AEs | Up to Day 7(+ 7 days) for the safety follow up post-dose |
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Inclusion Criteria:
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 -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.
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| Name | Affiliation | Role |
|---|---|---|
| Qian Chen | Shanghai Clinical Research Center Phase I Clinical Research Unit (SCRC-PCRU) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Clinical Research Center Phase I Clinical Research Unit (SCRC-PCRU) | Shanghai | Shanghai Municipality | China |
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| Placebo | Drug | Ascending single and multiple doses of placebo orally |
|