Trials / Completed
CompletedNCT03610035
A Study of NPT189 in Healthy Subjects
A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of NPT189 in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Proclara Biosciences, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
The purpose of the study is to evaluate the safety and tolerability of single dose of NPT189 in healthy volunteers. The study will also evaluate the pharmacokinetic characteristics of NPT189.
Detailed description
This study is a Phase1, randomized, double-blind, placebo-controlled, single dose, dose escalation safety and tolerability study of NPT189 in health subjects. Six dose cohorts are planned each with a maximum of 8 participants per cohort. Participants will receive NPT189 by intravenous (IV) or a matching placebo by intravenous infusion. Safety, tolerability, and pharmacokinetics will be assessed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NPT189 | IgG1 Fc-GAIM fusion protein, a recombinant fusion protein |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2018-07-24
- Primary completion
- 2019-02-17
- Completion
- 2019-02-17
- First posted
- 2018-08-01
- Last updated
- 2019-08-15
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT03610035. Inclusion in this directory is not an endorsement.