A Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of SNP-630 in Health Subjects.

• Status: Completed
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety, tolerability and Pharmacokinetic profile of SNP-630 when oral administered to healthy subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sinew Pharma Inc.

Criteria

Inclusion Criteria:

• A subject can participate in the study only if all the following criteria are met:

1. Between 20 and 45 years

2. Body weight 55 - 95 kg and body mass index (BMI) within the range 19 - 30 kg/m2

3. 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.)

4. Male or Female of non-reproductive potential

5. Able to provide written informed consent, and understand and comply with the requirements of the study

Exclusion Criteria:

• Subjects who meet any of the following criteria are not eligible to enter the study:

1. History of any significant medical condition (e.g. Cardiovascular, pulmonary, metabolic, renal, gastrointestinal, urological, psychological disease, etc.)

2. With any surgical or medical condition possibly affecting drug absorption (e.g. cholecystectomy, gastrectomy, bowel disease, etc.), distribution, metabolism or excretion

3. History of liver disease, or known hepatic or biliary abnormalities

4. Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test (anti-HBc Ab) result at screening

5. AST, ALT, gamma-GT and total bilirubin >1.0x ULN

6. Creatinine >1.0 x ULN

7. Donation of blood or blood products in excess of 500 mL within 3 months

8. Has participated in a clinical trial and has received an investigational product within 3 months prior to dosing

9. Pregnant or lactating

10. Anticipated requirement for any prescription medication during the study.

11. 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

12. 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