Healthy Volunteer
Conditions
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).
Interventions
DRUGPlacebo
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.
DRUGRG7625
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.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Netherlands
Outcome results
None listed