Trial | NCT03258502  Report issue

Title

Safety, Pharmacokinetics and Antiviral Activity of RV521 Against RSV
A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study To Evaluate The Safety, Pharmacokinetics And Antiviral Activity Of Multiple Doses Of RV521 Against Respiratory Syncytial Virus Infection In The Virus Challenge Model

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    RV521 ...

  • Study Participants

    66
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
Study Started
Jul 30
2017
Primary Completion
Oct 31
2017
Study Completion
Oct 31
2017
Last Update
Nov 07
2017

Drug RV521

RV521 drug in capsules

Drug Placebo

Placebo in capsules

RV521 Experimental

RV521 drug substance in capsule for oral administration

Placebo Placebo Comparator

Micro-crystalline cellulose in capsule for oral administration

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
No Results Posted