Clincosm LogoSign in Get a demo

A Phase I Study Evaluating Safety, Tolerability, PK and PD of BL-8040 for Stem Cell Mobilization in Healthy Volunteers

Sponsor
BioLineRx, Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02073019
Collaborator
(none)
33
Enrollment
1
Location
3
Arms
11
Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether BL-8040 is safe, tolerable and effective in the mobilization of Hematopoietic Stem Cells (HSC) in healthy volunteers

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Official Title:
A Phase I, Two Part Study Exploring the Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effect of Ascending Doses of BL-8040 in Healthy Subjects.
Study Start Date :
Aug 1, 2014
Actual Primary Completion Date :
Jul 1, 2015
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort A

Each subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion

Drug: BL-8040

Drug: Placebo
Experimental: Cohort B

Each subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion

Drug: BL-8040

Drug: Placebo
Experimental: Cohort C

Each subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion

Drug: BL-8040

Drug: Placebo

Outcome Measures

Primary Outcome Measures

  1. Number of subjects with Adverse Events [Up to 7 days after treatment comletion]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Healthy male subjects

  • BMI between 18 and 30 kg/m2 and Weight ≥ 60 Kg

  • Subjects must be either surgically sterilized (vasectomy), or if their partner is of childbearing potential, must use two methods of contraception, one of which must be a barrier method, from the first dose until 3 months after the last dose

  • Subject is able and willing to comply with the requirements of the protocol

Exclusion Criteria:

  • History of clinically significant disease

  • Any illness within the 4 weeks prior to the screening examination

  • Any history of alcohol and/or drug of abuse addiction and/or active / past (up to 2 years before screening) nicotine consumption

  • Clinically relevant deviation from normal in the physical examination and vital signs at screening or baseline

  • Clinically relevant laboratory abnormalities identified at screening or baseline

  • Positive tests at screening for HIV I & II, hepatitis B and/or hepatitis C in both parts or positive tests for Syphilis, HTLV I & II and Nucleic Acid Test (NAT) for HIV and HBV

  • Positive test for urine drugs of abuse or by anamnesis (Barbiturates, Benzodiazepines, Amphetamines, Opiates, Cocaine, Cannabinoids, Methadone, Phencyclidine, and Tricyclic Antidepressants) and/or positive alcohol blood test

  • Subjects who have lost or donated in excess of 400 mL of blood within 3 months prior to Day 1 of the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hadassah Clinical Research Center Jerusalem Israel

Sponsors and Collaborators

  • BioLineRx, Ltd.

Investigators

  • Study Chair: Arnon Aharon, MD, BioLineRx, Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
BioLineRx, Ltd.
ClinicalTrials.gov Identifier:
NCT02073019
Other Study ID Numbers:
  • BL-8040.02
First Posted:
Feb 27, 2014
Last Update Posted:
Jul 31, 2015
Last Verified:
Jul 1, 2015

Study Results

No Results Posted as of Jul 31, 2015