Trials / Completed
CompletedNCT03221179
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7049665 in Healthy Volunteers
A Randomized, Adaptive, Investigator/ Subject Blind, Single Ascending Dose, Placebo-Controlled Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered RO7049665 in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The primary objective of this study is to evaluate the safety and tolerability of single ascending doses of subcutaneous (SC) injections of RO7049665 in healthy volunteers. In addition, pharmacokinetics (PK) of RO7049665, the effects of single doses of RO7049665 on regulatory T-cells as well as the single dose immunogenicity of RO7049665 will be evaluated. This trial plans to evaluate approximately seven single dose-levels of RO7049665 or matching-placebo during dose-escalation in approximately 40 participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RO7049665 | A single ascending dose (starting dose 1.5 micrograms \[mcg\])of RO7049665 will be administered SC. |
| BIOLOGICAL | Placebo | Matching placebo will be administered SC once. |
Timeline
- Start date
- 2017-07-10
- Primary completion
- 2019-07-05
- Completion
- 2019-07-05
- First posted
- 2017-07-18
- Last updated
- 2019-08-13
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT03221179. Inclusion in this directory is not an endorsement.