A Multiple Ascending-Dose Study of RG7625 in Healthy Volunteers

NCT02521610 | Completed Phase 1

• 1 other identifier: BP29772
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

RG7625

EXPERIMENTAL

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.

Drug: RG7625

Interventions

Placebo DRUG

Participants will receive the placebo equivalent to RG7625 once or twice daily for 8 days. The first dose will be administered on Day 1 and the regimen will be continued during Days 3 to 9, with only a single dose given on Day 9.

Placebo

RG7625 DRUG

Participants will receive RG7625 as oral capsules once or twice daily for 8 days. The first dose will be administered on Day 1 and the regimen will be continued during Days 3 to 9, with only a single dose given on Day 9.

RG7625

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Zuidlaren, 9471 GP, Netherlands

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 13, 2015
• Study Start: August 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

NL (1)