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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
33
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.
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.
Unnamed facility
Zuidlaren, Netherlands
Change in concentration of 10-kilodalton (kDa) cluster of differentiation (CD) 74 intermediate (p10) in B-cells
Time frame: From Baseline (Day 1) to 24 hours after the Day 9 dose
Incidence of adverse events
Time frame: Up to 9 weeks
Change in size of induration from DTH response
Time frame: Up to 7 weeks
Area under the concentration-time curve (AUC) of RG7625
Time frame: Pre-dose at Baseline (Day 1) to 24 hours after the Day 9 dose
Maximum observed concentration (Cmax) of RG7625
Time frame: Pre-dose at Baseline (Day 1) to 24 hours after the Day 9 dose
Time to maximum observed concentration (Tmax) of RG7625
Time frame: Pre-dose at Baseline (Day 1) to 24 hours after the Day 9 dose
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