MedTrace Logo

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

NCT05293171 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-03-21

Study results available
· View outcomes & findings →

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.

Conditions

  • Healthy Subjects

Interventions

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

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • BioLineRx, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-11
Primary Completion
2022-06-01
Completion
2022-08-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05293171 on ClinicalTrials.gov