A Multiple Ascending-Dose Study of RG7625 in Healthy Volunteers

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02521610
• Other study ID #: BP29772
• Status: Completed
• Phase: Phase 1
• First received: August 10, 2015
• Last updated: November 1, 2016
• Start date: August 2015
• Est. completion date: November 2015

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Stichting Beoordeling Ethiek Biomedisch Onderzoek
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Placebo
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.
• RG7625
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Incidence of adverse events		Up to 9 weeks	No
Secondary	Change in size of induration from DTH response		Up to 7 weeks	No
Secondary	Area under the concentration-time curve (AUC) of RG7625		Pre-dose at Baseline (Day 1) to 24 hours after the Day 9 dose	No
Secondary	Maximum observed concentration (Cmax) of RG7625		Pre-dose at Baseline (Day 1) to 24 hours after the Day 9 dose	No
Secondary	Time to maximum observed concentration (Tmax) of RG7625		Pre-dose at Baseline (Day 1) to 24 hours after the Day 9 dose	No