A Multiple Ascending-Dose Study of RG7625 in Healthy Volunteers

Phase 1

Completed

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

• Registration Number: NCT02521610
• Lead Sponsor: Hoffmann-La Roche

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-10
• Study First Submitted QC: 2015-08-12
• Study First Posted: 2015-08-13
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Healthy adult males and females 18 to 60 years of age, inclusive
• Body mass index 18.0 to 30.0 kilograms per meter-squared (kg/m^2), inclusive

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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 electrocardiogram (ECG) or other risk factors for QT prolongation
• Use of prescribed or over-the-counter medication
• Inability or unwillingness to comply with study requirements

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Healthy volunteers will receive the placebo equivalent to RG7625 as oral capsules once or twice daily for 8 days. Each cohort will receive intradermal administration of 4 antigens (tetanus toxoid, tuberculin purified protein derivative \[PPD\], Candida albicans, and Trichophyton species) and a negative control at Screening and on Day 7 of treatment to assess for DTH.
RG7625	RG7625	Participants will undergo a series of Screening visits prior to treatment and 7- to 14-day follow-up. Healthy volunteers will be enrolled in up to 4 cohorts and will receive RG7625 as oral capsules once or twice daily for 8 days. The first cohort is planned to receive 100 milligrams (mg) on Day 1, followed by 100 mg twice daily on Days 3 to 9. Subsequent dose and frequency decisions will be based upon observations in previous cohort(s). Each cohort will receive intradermal administration of 4 antigens (tetanus toxoid, tuberculin PPD, Candida albicans, and Trichophyton species) and a negative control at Screening and on Day 7 of treatment to assess for DTH.

Primary Outcome Measures

Name	Time	Method
Change in concentration of 10-kilodalton (kDa) cluster of differentiation (CD) 74 intermediate (p10) in B-cells	From Baseline (Day 1) to 24 hours after the Day 9 dose

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	Up to 9 weeks
Change in size of induration from DTH response	Up to 7 weeks
Area under the concentration-time curve (AUC) of RG7625	Pre-dose at Baseline (Day 1) to 24 hours after the Day 9 dose
Maximum observed concentration (Cmax) of RG7625	Pre-dose at Baseline (Day 1) to 24 hours after the Day 9 dose
Time to maximum observed concentration (Tmax) of RG7625	Pre-dose at Baseline (Day 1) to 24 hours after the Day 9 dose