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
Abstract
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.
Primary outcome: QTc Effect of Single Subcutaneous (SC) Injections of Motixafortide (BL-8040) 1.25 mg/kg and 2 mg/kg.
Enrollment: 38 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 38 participants or records.
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