CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 38 enrolled
Drug / intervention
1.25 mg/kg BL-8040 + BL-8040-matching placebo +3 moredrug
Likely dose
1.25 mg/kg BL-8040 + BL-8040-matching placebofrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05293171
NCT05293171Phase 1Completed
CompareCT.gov

A Single-Dose, Randomized, Double-Blind, Placebo-Controlled, Positive-Controlled, Four-Way Crossover Study to Investigate the Effect of BL-8040 (Motixafortide) on the QTc Interval in Healthy Subjects

BioLineRx, Ltd.·interventional·Posted Mar 24, 2022·Updated Mar 21, 2025

In Brief

A Phase 1 clinical trial evaluating 1.25 mg/kg BL-8040 + BL-8040-matching placebo, 2 mg/kg BL-8040, and 2 other interventions for Healthy Subjects. Completed, enrolled 38 participants across 1 site.

Detailed Summary

The study will assess the corrected QT (QTc) effects (electrocardiogram \[ECG\]) of motixafortide (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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Subjects
CountriesUnited States
CollaboratorsCelerion

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedMar 24, 2022
Enrollment StartJun 11, 2021
Primary CompletionJun 1, 2022
Study CompletionAug 15, 2022
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 4.3 years ago

Interventions

1.25 mg/kg BL-8040 + BL-8040-matching placebodrug

Administered via subcutaneous (SC) injection

2 mg/kg BL-8040drug

Administered via subcutaneous (SC) injection

BL-8040-matching placebodrug

Administered subcutaneous (SC) injection

400 mg Moxifloxacin (1x400 mg tablet)drug

Administered orally