Trials / Completed
CompletedNCT01691924
Study To Assess the Safety and Tolerability of PBF-509 in Male Healthy Volunteers
Randomized, Double Blind, Placebo Controlled "First In-human" Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-509 in Male Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
No clinical trials with PBF-509 in humans have been performed to date. Only preclinical studies have been done to assess the pharmacology and pharmacokinetics, the safety and the toxicological profile of the PBF-509. An initial testing of PBF-509 in humans is planned, starting with the first-into-man clinical trial where a single oral, dose-escalating, and placebo-controlled design will be implemented.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PBF-509 | |
| DRUG | Placebo |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2013-10-01
- Completion
- 2013-10-01
- First posted
- 2012-09-25
- Last updated
- 2016-03-08
Locations
2 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT01691924. Inclusion in this directory is not an endorsement.