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.

Palobiofarma SL1 site in 1 country32 target enrollmentDecember 10, 2018

ConditionsPsoriasis

InterventionsPBF-1650 oral capsules Placebo oral capsule

DrugsPBF-1650 oral capsules Placebo oral capsule

Overview

Phase: Phase 1
Intervention: PBF-1650 oral capsules
Conditions: Psoriasis
Sponsor: Palobiofarma SL
Enrollment: 32
Locations: 1
Primary Endpoint: Number of Adverse events
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 10, 2018

End Date

May 31, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Sequential

Sex

Male

Investigators

Sponsor

Palobiofarma SL

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male subjects, 18-45 years (inclusive) of age at the time of enrollment.
•Males should agree to abstain from sexual intercourse with a female partner or agree to use a condom with spermicide, in addition to having their female partner use some contraceptive measures as oral contraceptive drugs, intrauterine hormonal contraception, or cervical caps until 28 days post-administration.
•Clinically acceptable blood pressure and pulse rate in supine and standing position (SBP between 140-100 mm Hg/ DBP between 90-50 mm Hg / HR between 100-50 bpm). Blood pressure and pulse will be measured after a minimum of 3 minutes of resting.
•Body weight within normal range (Quetelet's index between 19 and 26) expressed as weight (kg) / height (m2).
•Able to understand the nature of the study and comply with all their requirements.
•Free acceptance to participate in the study by obtains signed informed consent form approved by the Ethics Committee (CEIm).

Exclusion Criteria

•History of serious adverse reactions or hypersensitivity to any drug.
•Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).
•Background or clinical evidence of chronic diseases.
•Acute illness two weeks before drug administration.
•Having undergone major surgery during the previous 6 months.
•Smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the administration of the study medication).
•History of alcohol dependence or drug abuse in the last 5 years or daily consumption of alcohol \> 40 g or high consumption of stimulating beverages (\> 5 coffees, teas or coca cola drinks/ day).
•Abnormal physical findings of clinical significance at the screening examination or baseline which would interfere with the objectives of the study.
•Need of any prescription medication within 14 days prior to the administration of the investigational drug and non-prescription medication or herbal medicines within 7 days prior to the administration of the drug. Paracetamol (acetaminophen) is allowed, at doses up to 1 g daily, at the investigator discretion.
•Participation in other clinical trials during the previous 90 days in which an investigational drug or a commercially available drug was tested.