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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
Adenosine A3 receptor (AA3R) antagonist
solid microcrystalline cellulose
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Number of Adverse events
Adverse Events will be qualified according to the definitions and values stated in CTCAE V04 v4)
Time frame: 7 Days
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