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NCT Number: NCT02521610

A Multiple Ascending-Dose Study of RG7625 in Healthy Volunteers

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).

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Key information

Conditions

Healthy Volunteer

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Zuidlaren, 9471 GP, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Incidence of adverse events

    Time frame: Up to 9 weeks

  2. Change in size of induration from DTH response

    Time frame: Up to 7 weeks

  3. 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

  4. Maximum observed concentration (Cmax) of RG7625

    Time frame: Pre-dose at Baseline (Day 1) to 24 hours after the Day 9 dose

  5. Time to maximum observed concentration (Tmax) of RG7625

    Time frame: Pre-dose at Baseline (Day 1) to 24 hours after the Day 9 dose

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 13, 2015
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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