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Chemotherapy

2 mg/kg BL-8040 administered via SC injection (Supratherapeutic) for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by BioLineRx, Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up blood for pd (cd34+) is collected prior to study drug dosing and at 7 time points following each administration up to 24 hours . blood for pd (ro) is collected prior to study drug dosing and at 5 time points following each administration up to 24 hours.
Awards & highlights

Study Summary

The study will assess the corrected QT (QTc) effects (electrocardiogram [ECG]) of BL-8040 1.25 mg/kg (therapeutic dose) and 2 mg/kg (supratherapeutic dose) following a single subcutaneous (SC) injection relative to placebo in approximately 40 healthy subjects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~blood for pd (cd34+) is collected prior to study drug dosing and at 7 time points following each administration up to 24 hours . blood for pd (ro) is collected prior to study drug dosing and at 5 time points following each administration up to 24 hours.
This trial's timeline: 3 weeks for screening, Varies for treatment, and blood for pd (cd34+) is collected prior to study drug dosing and at 7 time points following each administration up to 24 hours . blood for pd (ro) is collected prior to study drug dosing and at 5 time points following each administration up to 24 hours. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of the QTc effects of BL-8040 1.25 mg/kg and 2 mg/kg following a single SC injection relative to placebo in healthy subjects
Secondary outcome measures
Assessment of the effects of single therapeutic and supratherapeutic SC injections of BL-8040 on non-QT interval ECG parameters
Evaluation of PK of single therapeutic and supratherapeutic SC injections of BL-8040 in healthy subjects.
Evaluation of assay sensitivity (i.e., to evaluate the effect of a positive control, a single oral 400 mg dose of moxifloxacin on the QTc interval in healthy subjects
+1 more
Other outcome measures
Evaluation of the PD effects (by assessing the peripheral blood CD34+ and peripheral blood receptor occupancy) of single therapeutic and supratherapeutic SC injections of BL-8040

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: 2 mg/kg BL-8040 administered via SC injection (Supratherapeutic)Experimental Treatment1 Intervention
2 mg/kg BL-8040 administered via SC injection (Supratherapeutic)
Group II: 1.25 mg/kg BL-8040 + BL-8040-matching placebo administered via SC injection (Therapeutic)Experimental Treatment1 Intervention
1.25 mg/kg BL-8040 + BL-8040-matching placebo administered via SC injection (Therapeutic)
Group III: 400 mg moxifloxacin (1 x 400 mg tablet) administered orallyActive Control1 Intervention
400 mg moxifloxacin (1 x 400 mg tablet) administered orally
Group IV: BL-8040-matching placebo administered via SC injectionPlacebo Group1 Intervention
BL-8040-matching placebo administered via SC injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
1.25 mg/kg BL-8040 + BL-8040-matching placebo
2021
Completed Phase 1
~40
2 mg/kg BL-8040
2021
Completed Phase 1
~40

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BioLineRx, Ltd.Lead Sponsor
21 Previous Clinical Trials
2,082 Total Patients Enrolled
CelerionIndustry Sponsor
81 Previous Clinical Trials
7,779 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study to Investigate the Effect of BL-8040 (Motixafortide) on the QTc Interval in Healthy Subjects
2021. "Study to Investigate the Effect of BL-8040 (Motixafortide) on the QTc Interval in Healthy Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05293171.
~10 spots leftby Apr 2025
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