Arrowhead Pharmaceuticals Initiates Phase 1/2a Studies for Two Pulmonary Candidates ARO-MUC5AC and ARO-RAGE
“Initiating clinical studies for ARO-MUC5AC and ARO-RAGE, Arrowhead’s next generation pulmonary targeted RNAi therapeutic candidates, is a significant milestone for the company,” said
AROMUC5AC-1001 (NCT05292950) is a Phase 1/2a, randomized, double-blinded, placebo-controlled study in up to 42 normal healthy volunteers (NHV) and up to 16 patients with moderate-to-severe asthma. The single ascending dose portion of the study includes 3 sequentially enrolled NHV cohorts with escalating single-dose levels. The multiple ascending dose portion of the study includes 3 NHV cohorts and 2 asthma patient cohorts. The objectives of the study include the assessment of safety and tolerability, pharmacokinetics, and pharmacodynamics of ARO-MUC5AC in NHVs and patients with asthma.
ARORAGE-1001 (NCT05276570) is a Phase 1/2a, randomized, double-blinded, placebo-controlled study in up to 64 NHVs and up to 16 patients with mild-to-moderate asthma. The single ascending dose portion of the study includes 4 sequentially enrolled NHV cohorts and one optional cohort treated with escalating single-dose levels. The multiple ascending dose portion of the study includes 4 NHV cohorts and 2 asthma patient cohorts. The objectives of the study include the assessment of safety and tolerability, pharmacokinetics, and pharmacodynamics of ARO-RAGE in NHVs and patients with asthma.
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