Trials / Completed
CompletedNCT03427710
A First In Human Study to Assess CiVi007 in Subjects With an Elevated LDL-Cholesterol Level
A Placebo-controlled, Single Blind, Randomised, Phase I, First In Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered CiVi007 in Subjects With an Elevated LDL C Level
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Civi Biopharma, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
The primary objective of the study is to assess pharmacokinetics, dynamics, safety and tolerability of CiVi007 following single and multiple subcutaneous doses in subjects, including those on statin therapy
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CiVi007 | cholesterol lowering drug |
| OTHER | Placebo | matching placebo to CiVi007 |
Timeline
- Start date
- 2018-02-07
- Primary completion
- 2020-02-14
- Completion
- 2020-08-18
- First posted
- 2018-02-09
- Last updated
- 2020-09-22
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03427710. Inclusion in this directory is not an endorsement.