Overview
Safety, Pharmacokinetics and Antiviral Activity of RV521 Against RSV
Status:
Completed
Completed
Trial end date:
2017-10-31
2017-10-31
Target enrollment:
0
0
Participant gender:
All
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 ModelPhase:
Phase 2Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
ReViral LtdTreatments:
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 =30kg/m2
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