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Trial record 1 of 1 for:    NCT02073019
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A Phase I Study Evaluating Safety, Tolerability, PK and PD of BL-8040 for Stem Cell Mobilization in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02073019
Recruitment Status : Completed
First Posted : February 27, 2014
Last Update Posted : July 31, 2015
Sponsor:
Information provided by (Responsible Party):
BioLineRx, Ltd.

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
Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB) Drug: BL-8040 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : August 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

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



Primary Outcome Measures :
  1. Number of subjects with Adverse Events [ Time Frame: Up to 7 days after treatment comletion ]


Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02073019


Locations
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Israel
Hadassah Clinical Research Center
Jerusalem, Israel
Sponsors and Collaborators
BioLineRx, Ltd.
Investigators
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Study Chair: Arnon Aharon, MD BioLineRx, Ltd.

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Responsible Party: BioLineRx, Ltd.
ClinicalTrials.gov Identifier: NCT02073019     History of Changes
Other Study ID Numbers: BL-8040.02
First Posted: February 27, 2014    Key Record Dates
Last Update Posted: July 31, 2015
Last Verified: July 2015