Status:
COMPLETED
A Study of RG7625 in Healthy Volunteers
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This is a single center, randomized, double-blind, placebo-controlled, single ascending dose study that will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of single d...
Eligibility Criteria
Inclusion
- Healthy male and female participants, 18 to 60 years of age, inclusive
- A body mass index between 18 to 30 kg/m2 inclusive
- Able to participate and willing to give written informed consent and to comply with the study restrictions
Exclusion
- Any clinically relevant abnormalities, concomitant diseases or ongoing medical conditions, abnormal laboratory test results or a history of any other clinically significant disorders
- Any major illness within the one month preceding the screening visit, or any febrile illness within the two weeks preceding the screening visit
- Any significant allergic reaction to drugs
- Immunocompromised or with reduced immune function and/or immunization within 30 days before the first study drug administration or planning vaccination during the study
- Women who are pregnant or lactating or of childbearing potential
- Clinically significant abnormal ECG or other risk factors for QT prolongation
- Use of prescribed or over the counter medication
- Inability or unwillingness to comply with study requirements
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT02295332
Start Date
December 1 2014
End Date
April 1 2015
Last Update
November 2 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Zuidlaren, Netherlands, 9471 GP