drugset / Trial / NCT02521610

A Multiple Ascending-Dose Study of RG7625 in Healthy Volunteers

NCT02521610 ↗

Phase 1 Completed 33 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindBasic science

Summary

This randomized, double-blind, placebo-controlled, ascending-dose, parallel-group study will evaluate the pharmacodynamic effects, pharmacokinetics, safety, and tolerability of one week of RG7625 dosing in healthy male and female volunteers. Each participant will receive a single dose of RG7625 or placebo followed by one week of dosing with the same treatment. Each participant will also receive intradermal administration of 4 recall antigens at Screening and on Day 7 of treatment to assess study drug effects on delayed-type hypersensitivity (DTH).

Timeline

Start
2015-08
Primary completion
2015-11
Completion
2015-11

Drugs

EvaluationDrugModalityDoseRoute
Subject PETESICATIB Small molecule 100 mg Oral

Indications

No indication recorded.