Trials / Completed
CompletedNCT01885624
Open Label Phase 1 Pharmacokinetics and Tolerability Study of Single TAB08 Administration in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Theramab LLC · Industry
- Sex
- Male
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess safety and tolerability of ascending dosed of TAB08 after single i.v. infusion to the adult healthy volunteers. Additionally were assessed infusion speed tolerability, pharmacokinetics and pharmacodynamics of TAB08 after single i.v. infusion and to explore TAB mechanism-of-action biomarkers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | TAB08 | monoclonal antibody |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2013-05-01
- Completion
- 2013-06-01
- First posted
- 2013-06-25
- Last updated
- 2017-02-15
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT01885624. Inclusion in this directory is not an endorsement.