Trials / Completed
CompletedNCT03148925
Safety and Pharmacodynamcis of SELA-070 Nicotine Vaccine in Smokers
A Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Pharmacodynamics of Increasing Subcutaneous Doses of SELA-070 in Healthy Adult Smokers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Selecta Biosciences, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the safety and pharmacodynamics of SELA-070. Increasing subcutaneous doses of SELA-070 will be administered to healthy smoker volunteers. The resulting safety profile and anti-nicotine antibody levels will be evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SELA-070 | Sub-cutaneous injection, multiple dose |
| BIOLOGICAL | Saline | Sub-cutaneous injection, multiple dose |
Timeline
- Start date
- 2017-05-11
- Primary completion
- 2018-10-18
- Completion
- 2018-10-18
- First posted
- 2017-05-11
- Last updated
- 2018-11-16
Locations
1 site across 1 country: Belgium
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03148925. Inclusion in this directory is not an endorsement.