The Pharmacokinetics (PK), Safety, Tolerability of SR750 in Healthy Volunteers
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SR750 tablet Ascending single and multiple doses of SR750 orally |
Drug: SR750 tablet
Ascending single and multiple doses of SR750 orally
|
| Placebo Comparator: Placebo Ascending single and multiple doses of placebo orally |
Drug: Placebo
Ascending single and multiple doses of placebo orally
|
Outcome Measures
Primary Outcome Measures
- Cmax [Up to Day 9]
Peak plasma concentration
- Tmax [Up to Day 9]
Time of peak plasma concentration
- AUC [Up to Day 9]
Area under the plasma concentration-time curve
- CL/F [Up to Day 9]
Apparent oral clearance
- t1/2 [Up to Day 9]
Terminal half-life
- Rac [Up to Day 9]
Accumulation ratio
Secondary Outcome Measures
- AE: Adverse Event [Up to Day14(+7 days) for the safety follow up since Day1]
The frequency and severity of althy volunteers administrated with single and repeated oral doses of SR750 AEs
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy males and females who are 18 to 45 years of age.
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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.
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Bodyweight of male > 50 kg, Bodyweight of female > 45 kg and body mass index (BMI) between 18 and28 kg/m2
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Male subjects must agree to use contraception methods.
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Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion Criteria:
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Known history of renal dysfunction or creatinine clearance < 90 mL/min (calculated using the Cockcroft-Gault formula) at Screening.
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Current or chronic history of liver disease or known hepatic or biliary abnormalities.
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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.
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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.
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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.
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History of asthma (excluding resolved childhood asthma), severe allergic responses.
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History of hypercoagulable state or history of thrombosis.
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A positive Hepatitis B surface antigen, positive Hepatitis C antibody and positive test for human immunodeficiency virus (HIV) antibody.
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Within 6 months of screening, Smoking more than 4 cigarettes per day (including e-cigarettes).
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A positive drug/alcohol result at Screening or Day -1.
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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.
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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.
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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.
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Female subjects with positive pregnancy test results.
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The investigator will determine any conditions in which subjects are not suitable for the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai Clinical Research Center Phase I Clinical Research Unit (SCRC-PCRU) | Shanghai | China |
Sponsors and Collaborators
- Shanghai SIMR Biotechnology Co., Ltd.
Investigators
- Principal Investigator: Chen Yu, Shanghai Clinical Research Center Phase I Clinical Research Unit (SCRC-PCRU)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SR750-102