Overview

Safety, Pharmacokinetics and Antiviral Activity of RV521 Against RSV

Status:
Completed
Trial end date:
2017-10-31
Target enrollment:
0
Participant gender:
All
Summary
The main aims of the study are to assess the safety, pharmacokinetics and antiviral activity of multiple doses of RV521 compared to placebo in healthy adult subjects infected with Respiratory Syncytial Virus (RSV) in the Virus Challenge Model
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
ReViral Ltd
Treatments:
Antiviral Agents
Criteria
Inclusion Criteria:

- Age 18 to 45 years, inclusive

- In good health with no history of major medical conditions

- A total body weight ≥ 50 kg and a body mass index (BMI) of >/=18kg/m2 and
Exclusion Criteria:

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

- Positive for Human Immunodeficiency Virus, active Hepatitis A, B or C test

- Significant nose or nasopharynx abnormalities

- Abnormal lung function

- History or currently active symptoms suggestive of upper or lower respiratory tract
infection