Study to Assess the Safety and Tolerability of PBF-1650 in Healthy Volunteers.
NCT03798236 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2020-06-30
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).
Conditions
Interventions
- DRUG
-
PBF-1650 oral capsules
Adenosine A3 receptor (AA3R) antagonist
- DRUG
-
Placebo oral capsule
solid microcrystalline cellulose
Sponsors & Collaborators
-
Clínica Universidad de Navarra
collaborator UNKNOWN -
Palobiofarma SL
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-12-10
- Primary Completion
- 2019-03-30
- Completion
- 2019-05-31
Countries
- Spain
Study Locations
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