Trials / Completed
CompletedNCT00822341
Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of TG-0054 With Single IV Doses Escalation in Healthy Volunteers
A Randomized, Double-Blind, Placebo-Controlled, Sequential Ascending Single Intravenous Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TG-0054 in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 64 (actual)
- Sponsor
- GPCR Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
TG-0054 is a CXCR4 antagonist with stem cell mobilization effect as proven in animal model, this is the fist in human study to investigator the safety, tolerability and PK/PD in healthy subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TG-0054 | 0.10, 0.14, 0.28, 0.56, 1.12, 2.24, 3.14, and 4.40 mg/kg of TG-0054/placebo via 15 min IV infusion |
Timeline
- Start date
- 2008-04-01
- Primary completion
- 2009-05-01
- Completion
- 2009-05-01
- First posted
- 2009-01-14
- Last updated
- 2021-08-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00822341. Inclusion in this directory is not an endorsement.