A Study of RG7625 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: Placebo; Drug: RG7625

• Registration Number: NCT02295332
• Lead Sponsor: Hoffmann-La Roche

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 doses of RG7625 in healthy male and female volunteers.

The study will employ an interleaved cohort ('leapfrog') design in which dosing is alternated between two cohorts and each individual within a cohort will receive study drug dosing on four occasions - in effect giving a four treatment, four period, four-way crossover for each individual. The minimum duration for each participant is approximately 8 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-17
• Study First Submitted QC: 2014-11-17
• Study First Posted: 2014-11-20
• Study Start: 2014-12
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• 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

Read More

Exclusion Criteria

• 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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort A	Placebo	-
Cohort A	RG7625	-
Cohort B	Placebo	-
Cohort B	RG7625	-

Primary Outcome Measures

Name	Time	Method
Safety (composite outcome measure):Incidence and severity of adverse events (AEs), laboratory abnormalities, changes in ECG, vital signs	Approximately 22 weeks

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics (composite outcome measure): measurement of intracellular p10 concentrations and cell surface expression of major histocompatibility complex class (MHC)-II, relationship to RG7625 exposure	22 weeks
Pharmacokinetics (composite outcome measure): PK profile and parameters derived from plasma concentrations of RG7625 and its metabolites [AUCinf, AUClast, Cmax, tmax, t1/2, CL/F, V/F, Ae, fe and CLR]	22 weeks