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

NCT03798236 | Completed Phase 1

• 1 other identifier: PBF-1650CT-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Psoriasis

Keywords

Adenosine A3 receptor antagonist; autoimmune diseases; Immune modulator

Outcome Measures

Primary Outcomes (1)

• Number of Adverse events

  Adverse Events will be qualified according to the definitions and values stated in CTCAE V04 v4)

  7 Days

Study Arms (5)

PBF-1650 40mg

EXPERIMENTAL

Drug: PBF-1650 oral capsules

PBF-1650 80mg

EXPERIMENTAL

Drug: PBF-1650 oral capsules

PBF-1650 120mg

EXPERIMENTAL

Drug: PBF-1650 oral capsules

PBF-1650 240mg

EXPERIMENTAL

Drug: PBF-1650 oral capsules

Placebo

PLACEBO COMPARATOR

Drug: Placebo oral capsule

Interventions

PBF-1650 oral capsules DRUG

Adenosine A3 receptor (AA3R) antagonist

PBF-1650 120mg; PBF-1650 240mg; PBF-1650 40mg; PBF-1650 80mg

Placebo oral capsule DRUG

solid microcrystalline cellulose

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Existence of any surgical or medical condition which might interfere with the absortion, distribution, metabolism or excretion of the drug, i.e. impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhea or conditions associated with total or partial obstruction of the urinary tract
• lead ECG obtained at screening with PR ≥ 220 msec, QRS ≥120 msec and QTc ≥ 440 msec, bradychardia (\<50 bpm) or clinically significant minor ST wave changes or any other abnormal changes on the screening ECG that would interfere with measurement of the QT interval.
• Symptoms of a significant somatic or mental illness in the four-week period preceding drug administration.
• History of hepatitis HBV and / or HCV and / or positive serology results, which indicate the presence of hepatitis B surface antigen and / or detectable HCV ribonucleic acid (RNA).
• Positive results from the HIV serology.

Sponsors & Collaborators

• Palobiofarma SL: lead
• Clínica Universidad de Navarra: collaborator

Study Sites (1)

Clinica Universidad de Navarra

Pamplona, Navarre, 31007, Spain

Location

MeSH Terms

Conditions

Psoriasis; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single center, randomized, double-blind, placebo-controlled clinical study.

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 9, 2019
• Study Start: December 10, 2018
• Primary Completion: March 30, 2019
• Study Completion: May 31, 2019
• Last Updated: June 30, 2020

Record last verified: 2020-06

Locations

ES (1)