A Phase I Study Evaluating Safety, Tolerability, PK and PD of BL-8040 for Stem Cell Mobilization in Healthy Volunteers
NCT ID: NCT02073019
Last Updated: 2015-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
33 participants
INTERVENTIONAL
2014-08-31
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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Cohort A
Each subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion
BL-8040
Placebo
Cohort B
Each subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion
BL-8040
Placebo
Cohort C
Each subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion
BL-8040
Placebo
Interventions
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BL-8040
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
MALE
Yes
Sponsors
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BioLineRx, Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Arnon Aharon, MD
Role: STUDY_CHAIR
BioLineRx, Ltd.
Locations
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Hadassah Clinical Research Center
Jerusalem, , Israel
Countries
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Other Identifiers
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BL-8040.02
Identifier Type: -
Identifier Source: org_study_id