NCT03798236

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Palobiofarma SL · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	PBF-1650 oral capsules	Adenosine A3 receptor (AA3R) antagonist
DRUG	Placebo oral capsule	solid microcrystalline cellulose

Timeline

• Start date: 2018-12-10
• Primary completion: 2019-03-30
• Completion: 2019-05-31
• First posted: 2019-01-09
• Last updated: 2020-06-30

Locations

1 site across 1 country: Spain