A Multiple Ascending-Dose Study of RG7625 in Healthy Volunteers

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: RG7625; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02521610

BP29772

Details and patient eligibility

About

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).

Enrollment: 33 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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33 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

RG7625

Experimental group

Description:

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.

Treatment:

Drug: RG7625