Trials / Completed
CompletedNCT02868996
An Open Label, Phase 1b, Ascending Dose Study of DM199
An Open Label, Phase 1b, Single CENTER, Ascending Dose Study TO ASSESS THE SAFETY AND TOLERABILITY of DM199 With a Comparative Pharmacokinetic Study of DM199 Administered Intravenously and a Bioavailability Assessment of Subcutaneous Administration of DM199 in Normal Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- DiaMedica Therapeutics Inc · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
This is a Phase 1B study to assess the safety, tolerability and pharmacokinetics of DM199 in healthy volunteers. The study will be consist of two parts: Part A will focus on intravenous dosing and Part B will directly compare intravenous dosing with subcutaneous dosing.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Recombinant human tissue kallikrein | Intravenous DM199 |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2017-03-01
- Completion
- 2017-03-01
- First posted
- 2016-08-16
- Last updated
- 2017-12-07
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT02868996. Inclusion in this directory is not an endorsement.