Study to Investigate the Effect of BL-8040 (Motixafortide) on the QTc Interval in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

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.
    

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 PK samples, and blood
      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.
    

Intervention name(s): 1.25 mg/kg BL-8040 + BL-8040-matching placebo; 2 mg/kg BL-8040; BL-8040-matching placebo; 400 mg Moxifloxacin (1x400 mg tablet)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered via subcutaneous (SC) injection; Administered via subcutaneous (SC) injection; Administered subcutaneous (SC) injection; Administered orally
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model 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. On Day 1 of Period 1, subjects will be randomized to 1 of 12 treatment sequences.
Each treatment sequence comprises 4 treatment periods. Each subject will be assigned a unique identification number upon screening. Subjects who complete the study screening assessments and meet all the eligibility criteria will be assigned a unique randomization identification number at the time of the first dosing, different from the screening number, and will receive the corresponding study drug, according to a randomization scheme.
Subjects will receive each of the 4 Treatments in a pre-defined order according to the sequence scheme determined at randomization.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other