CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 36 enrolled
Drug / intervention
RG-HRV16 +1 morebiological
Likely dose
Placebo 2 mlfrom record
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Search/NCT01769573
NCT01769573Phase 1Completed
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A First-in-Human Safety and Dose-Finding Study of New Type-16 Human Rhinovirus (RG-HRV16) Inoculum in Healthy Volunteers

University of Wisconsin, Madison·interventional·Posted Jan 16, 2013·Updated Jun 3, 2019

In Brief

A Phase 1 clinical trial evaluating RG-HRV16 and Placebo for Healthy Volunteers. Completed, enrolled 36 participants across 1 site.

Detailed Summary

This research study will test different doses of RG-HRV16 to find the minimum dose needed to give research subjects cold symptoms of at least moderate intensity. The study will also test the safety of RG-HRV16. This information will be used in future studies (for example, to test antiviral preparations, sprays that could protect from getting a cold or decrease cold symptoms or to understand more about how rhinovirus can lead to asthma worsening). RG-HRV16 is a common cold virus that has been made in a new way and has not been used in humans before.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 16, 2013
Enrollment StartJul 1, 2013
Primary CompletionNov 1, 2016
Study CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 13.5 years ago

Interventions

RG-HRV16biological

A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin

Placebodrug

The placebo to be used will be Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin. Placebo will be supplied in 2 ml borosilicate glass vials sealed with butyl stoppers containing 0.5 ml.