Loading clinical trials...

Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-999 in Healthy Young Male Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-999 in Healthy Young Male Volunteers

Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-999 ( 5 mg, 10 mg, 20 mg and 40 mg ) in Healthy Young Male Volunteers

NCT02208934•Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

View on ClinicalTrials.gov

Summary

Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-999 ( 5 mg, 10 mg, 20 mg and 40 mg ) in Healthy Young Male Volunteers

Eligibility

Age

18 - 45 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy male subjects, 18-45 years (inclusive) of age at the time of enrollment.
•2. 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 until 28 days post-administration.
•3. Clinically acceptable blood pressure and pulse rate in supine and standing position. Blood pressure and pulse will be measured after a minimum of 3 minutes of resting.
•4. Body weight within normal range (Quetelet's index between 19 and 26) expressed as weight (kg) / height (m2).
•5. Able to understand the nature of the study and comply with all their requirements.
•6. Free acceptance to participate in the study by obtains signed informed consent form approved by the Ethics Committee of the Hospital (CEIC).

Exclusion Criteria

•1. History of serious adverse reactions or hypersensitivity to any drug.
•2. Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).
•3. Background or clinical evidence of chronic diseases.
•4. Acute illness two weeks before drug administration.
•5. Having undergone major surgery during the previous 6 months.
•6. Smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the administration of the study medication.
•7. 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).
•8. Abnormal physical findings of clinical significance at the screening examination or baseline which would interfere with the objectives of the study.
•9. Need of any prescription medication within 14 days prior to the administration of the drug and non prescription medication or herbal medicines within 7 days prior to the administration of the drug.
•10. Participation in other clinical trials during the previous 90 days in which an investigational drug or a commercially available drug was tested.
+10 more criteria

Locations (2)

CIM-Sant Pau - IIB Sant Pau, HSCSP

Barcelona, Barcelona, Spain

Palobiofarma S.L. (molecule owner)

Mataró, Barcelona, Spain

Key Dates

Start Date

September 1, 2014

Primary Completion Date

October 1, 2015

Completion Date

October 1, 2015

Last Updated

March 8, 2016

Enrollment

ACTUAL participants

Conditions

Huntington's Disease

Interventions

PBF-999

DRUG

Placebo

DRUG

HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease

NCT02855476

Huntington's Disease

View study

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

Safety and Proof-of-Concept (POC) Study With AMT-130 in Adults With Early Manifest Huntington's Disease

NCT04120493

Huntington's Disease

View study

COMPLETEDPHASE2

A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 8, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-999 in Healthy Young Male Volunteers

Inclusion Criteria

Exclusion Criteria

HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease

Safety and Proof-of-Concept (POC) Study With AMT-130 in Adults With Early Manifest Huntington's Disease

A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD)

Study to Measure Cerebrospinal Fluid Mutant Huntingtin Protein in Participants With Early Manifest Stage I or Stage II Huntington's Disease

A Study of Treatment With Pridopidine (ACR16) in Participants With Huntington's Disease

Safety and Tolerability of WVE-120101 in Patients With Huntington's Disease