Study to Assess the Safety and Tolerability of PBF-1650 in Healthy Volunteers. — ADENOIMMUNE  

Psoriasis Clinical Trial

Official title: Randomized, Double Blind, Placebo Controlled "First-in-human" Study to Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-1650 (40 mg, 80 mg, 120 and 240 mg) in Healthy Young Male Volunteers.

Status Completed

Clinical Trial Summary

Single center, randomized, double-blind, placebo-controlled clinical study to assess the safety and tolerability of PBF-1650 in order to obtain the Maximum Tolerated Dose (MTD).

Clinical Trial Description

The clinical trial will be a dose escalation study without therapeutic benefit, in which PBF-1650 will be administered as single oral ascending- dose to healthy young male volunteers. Up to four different rising doses will be tested (40 mg, 80 mg, 120 and 240 mg) in groups/cohorts of 8 participants. Thus, four groups/cohorts will participate. For each dose level / group, the participants will be randomized to active or placebo with 2 participants being randomly assigned to placebo and 6 to the active drug. First, one volunteer will receive active drug (subgroup 1); after at least 48h of safety and tolerability assessment a second subgroup of 3 volunteers will receive 2 active drug and 1 placebo; after at least another 48h of safety and tolerability parameters assessment a third subgroup of 4 volunteers will receive 3 active drug and 1 placebo. After evaluation of safety parameters of corresponding dose level, the process will replicate one week afterwards in the following dosages.

The pharmacokinetics profile of PBF-1650 after single oral dose administration of the four dose levels will be also assessed. ;

Related Conditions & MeSH terms

• Psoriasis

• NCT number: NCT03798236
• Study type: Interventional
• Source: Palobiofarma SL
• Status: Completed
• Phase: Phase 1
• Start date: December 10, 2018
• Completion date: May 31, 2019