NCT05293171

Study to Investigate the Effect of BL-8040 (Motixafortide) on the QTc Interval in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: BioLineRx, Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a randomized, double-blind (in respect to BL-8040 and BL-8040-matching placebo dosing), placebo- and positive-controlled, 4-period, 4-way crossover study in healthy subjects. A continuous 12-lead cardiodynamic ECG recording will be collected for approximately 24 hours on Day -1 of Period 1 for use in the optimized individual corrected QTc (QTcI) baseline calculations. On Day 1 of Period 1, subjects will be randomized to 1 of 12 treatment sequences. Each treatment sequence comprises 4 treatment periods. On Day 1 of each period, subjects will receive single-dose SC injection of BL-8040 (therapeutic or supratherapeutic dose), single-dose SC injection of BL-8040-matching placebo, or a single oral dose of moxifloxacin. Cardiodynamic readings, plasma pharmacokinetic (PK) samples, and blood pharmacodynamic (PD) samples will be collected at different time points prior to dosing and up to 24 hours postdose in each period, as appropriate. There will be a washout period of 5-7 days between dosing in each period. All subjects who received at least one dose of any study drug (including subjects who terminate the study early) will return to the clinical research unit (CRU) 7 ± 2 days after the last dose for follow-up procedures, and to determine if any adverse event (AE) has occurred since the last study visit.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	1.25 mg/kg BL-8040 + BL-8040-matching placebo	Administered via subcutaneous (SC) injection
DRUG	2 mg/kg BL-8040	Administered via subcutaneous (SC) injection
DRUG	BL-8040-matching placebo	Administered subcutaneous (SC) injection
DRUG	400 mg Moxifloxacin (1x400 mg tablet)	Administered orally

Timeline

• Start date: 2021-06-11
• Primary completion: 2022-06-01
• Completion: 2022-08-15
• First posted: 2022-03-24
• Last updated: 2025-03-21
• Results posted: 2025-03-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study