drugset
drugset / Trial / NCT01691924

Study To Assess the Safety and Tolerability of PBF-509 in Male Healthy Volunteers

NCT01691924 ↗

Phase 1 Completed 56 enrolled Sant Pau Research Institute Palo Biofarma, S.L · collab
RandomizedParallel-groupDouble-blind

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.

Timeline

Start
2012-10
Primary completion
2013-10
Completion
2013-10

Drugs

EvaluationDrugModalityDoseRoute
Subject PBF-509 Unknown 10 mg Oral
Subject PBF-509 Unknown 20 mg Oral
Subject PBF-509 Unknown 40 mg Oral
Subject PBF-509 Unknown 80 mg Oral
Subject PBF-509 Unknown 160 mg Oral
Subject PBF-509 Unknown 320 mg Oral
Subject PBF-509 Unknown 480 mg Oral
Subject PBF-509 Unknown 620 mg Oral

Indications

Parkinson disease