Study To Assess the Safety and Tolerability of PBF-509 in Male Healthy Volunteers
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
|Official Title:||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|
- Number of Adverse Events [ Designated as safety issue: Yes ]Safety and Tolerability evaluation
- Pharmacokinetic profile analysis [ Designated as safety issue: No ]
|Study Start Date:||October 2012|
|Placebo Comparator: Placebo||Drug: Placebo|
|Experimental: PBF-509||Drug: PBF-509|
|Contact: Claudia E. Delgado, MDemail@example.com|
|Principal Investigator:||Rosa M. Antonijoan, MD||Centre de Investigació de Medicaments. Hospital de la Santa Creu i Sant Pau|