Clinical trial NCT02521610: A Multiple Ascending-Dose Study of RG7625 in Healthy Volunteers
Official title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose Study to Investigate the Pharmacokinetics, Pharmacodynamic Effects, Safety and Tolerability of Repeated Dosing of RO5459072 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-08-13
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: 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

Primary outcomes:
measure: Change in concentration of 10-kilodalton (kDa) cluster of differentiation (CD) 74 intermediate (p10) in B-cells
timeFrame: From Baseline (Day 1) to 24 hours after the Day 9 dose
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 9 weeks
measure: Change in size of induration from DTH response
timeFrame: Up to 7 weeks
measure: Area under the concentration-time curve (AUC) of RG7625
timeFrame: Pre-dose at Baseline (Day 1) to 24 hours after the Day 9 dose
measure: Maximum observed concentration (Cmax) of RG7625
timeFrame: Pre-dose at Baseline (Day 1) to 24 hours after the Day 9 dose
measure: Time to maximum observed concentration (Tmax) of RG7625
timeFrame: Pre-dose at Baseline (Day 1) to 24 hours after the Day 9 dose
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: