Safety, Pharmacokinetics and Antiviral Activity of RV521 Against RSV

• Sponsor: ReViral Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03258502
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.1
• Patients Per Site Per Month: 21.6

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Virus Infections	Drug: RV521; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Jul 30, 2017
• Actual Primary Completion Date: Oct 31, 2017
• Actual Study Completion Date: Oct 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RV521 RV521 drug substance in capsule for oral administration	Drug: RV521; RV521 drug in capsules
Placebo Comparator: Placebo Micro-crystalline cellulose in capsule for oral administration	Drug: Placebo; Placebo in capsules

Outcome Measures

Primary Outcome Measures

1. Change in viral load [Baseline to study day 12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	hVIVO Services Ltd	London		United Kingdom

Sponsors and Collaborators

• ReViral Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ReViral Ltd
• ClinicalTrials.gov Identifier: NCT03258502
• Other Study ID Numbers: REVC002; 2017-001282-24
• First Posted: Aug 23, 2017
• Last Update Posted: Nov 7, 2017
• Last Verified: Nov 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Virus Diseases; Respiratory Syncytial Virus Infections

Study Results

No Results Posted as of Nov 7, 2017