Status:
COMPLETED
A Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of SNP-630 in Health Subjects.
Lead Sponsor:
Sinew Pharma Inc.
Conditions:
NASH - Nonalcoholic Steatohepatitis
Eligibility:
All Genders
20-45 years
Phase:
PHASE1
Brief Summary
To evaluate the safety, tolerability and Pharmacokinetic profile of SNP-630 when oral administered to healthy subjects.
Detailed Description
A Phase 1 Single Dose Study to investigate the safety, tolerability and Pharmacokinetic profile of SNP-630 in Health Subjects To evaluate the safety, tolerability and Pharmacokinetic profile of SNP-63...
Eligibility Criteria
Inclusion
- A subject can participate in the study only if all the following criteria are met:
- Between 20 and 45 years
- Body weight 55 - 95 kg and body mass index (BMI) within the range 19 - 30 kg/m2
- Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECG. (A subject with a clinically insignificant abnormality or laboratory parameter(s) may be included only if the Investigator documents that the finding is unlikely to represent a safety risk and will not interfere with the study procedures.)
- Male or Female of non-reproductive potential
- Able to provide written informed consent, and understand and comply with the requirements of the study
Exclusion
- Subjects who meet any of the following criteria are not eligible to enter the study:
- History of any significant medical condition (e.g. Cardiovascular, pulmonary, metabolic, renal, gastrointestinal, urological, psychological disease, etc.)
- With any surgical or medical condition possibly affecting drug absorption (e.g. cholecystectomy, gastrectomy, bowel disease, etc.), distribution, metabolism or excretion
- History of liver disease, or known hepatic or biliary abnormalities
- Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test (anti-HBc Ab) result at screening
- AST, ALT, gamma-GT and total bilirubin \>1.0x ULN
- Creatinine \>1.0 x ULN
- Donation of blood or blood products in excess of 500 mL within 3 months
- Has participated in a clinical trial and has received an investigational product within 3 months prior to dosing
- Pregnant or lactating
- Anticipated requirement for any prescription medication during the study.
- History of sensitivity to any of the study medications, or components thereof or a history of anaphylaxis or severe allergy to drug or other substances
- History or presence of alcohol abuse, defined as consumption of more than 210 mL of alcohol per week (the equivalent of 14 glasses of 120-mL wine or 14 cans of 350-mL beer), or other substance abuse within the prior two years
Key Trial Info
Start Date :
July 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2021
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04808154
Start Date
July 22 2021
End Date
August 31 2021
Last Update
October 11 2021
Active Locations (1)
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1
Tri-Service General Hospital
Taipei, Taiwan, 114