Pharmacokinetics and Safety of RV521 Formulations

• Status: Completed
• Trial end date: 2019-09-09
• Target enrollment: 0
• Participant gender: All

Summary

The main aims of the study are to assess the pharmacokinetics and safety of single doses of RV521 administered as two different formulations

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

Details

• Lead Sponsor: ReViral Ltd

Criteria

Inclusion Criteria:

• Willing to comply with protocol defined contraception requirements

• In good health with no history of major medical conditions

• A body mass index (BMI) of 18-25 kg/m^2, inclusive

Exclusion Criteria:

• Evidence of any clinically significant or currently active major medical condition

• Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening

• Not willing to comply with protocol defined restrictions for intake of drugs of abuse, alcohol, nicotine-containing products, medication (prescription, OTC, herbal, vitamins/minerals etc) and specified food and drink products