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ARO-MUC5AC in Healthy Subjects and Patients With Muco-Obstructive Lung Disease
NCT05292950Phase 2
Key facts
- Status
- Terminated
- Start
- Jun 2022
- Primary completion
- Nov 2024
- Countries
- 7
- Sponsor
- Arrowhead Pharmaceuticals
- Modality
- Conjugated siRNA, Chemically Modified siRNA
- Drugs
- ARO-MUC5AC
- Conditions
- asthmachronic obstructive pulmonary disease (COPD)
01
Overview
Phase 2, randomised, double-blind trial of ARO-MUC5AC in asthma and chronic obstructive pulmonary disease (COPD) (14 arms), sponsored by Arrowhead Pharmaceuticals. Primary endpoint: Treatment-Emergent Adverse Events at Day 85. Started Jun 2022; status: terminated.
02
Design
14 arms- Study design
- RandomizedDouble-blind
NHV (SAD): Pooled Placebo
Single dose of placebo on Day 1
NHV (SAD): ARO-MUC5AC 24 mg
Single dose of ARO-MUC5AC 24 mg on Day 1
NHV (SAD): ARO-MUC5AC 56 mg
Single dose of ARO-MUC5AC 56 mg on Day 1
NHV (SAD): ARO-MUC5AC 108 mg
Single dose of ARO-MUC5AC 108 mg on Day 1
NHV (SAD): ARO-MUC5AC 232 mg
Single dose of ARO-MUC5AC 232 mg on Day 1
NHV (MAD): Pooled Placebo
3 doses of placebo on Days 1, 15, and 29
8 more in the full profile.
03
Who it enrols
Includes normal healthy volunteers, patients with moderate-to-severe asthma, and patients with moderate-to-severe COPD. Asthma patients must be on stable controller medications. COPD patients must have a smoking history of >= 10 pack-years. Excludes patients with recent respiratory infections, positive COVID-19 test, HIV, HBV, HCV, uncontrolled hypertension, or recent use of theophylline.
04
Endpoints
Primary
Treatment-Emergent Adverse Events
Secondary
Forced Expiratory Volume in 1 second
Forced Vital Capacity
Maximum Observed Plasma Concentration
Time to Maximum Observed Plasma Concentration
Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration
Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours
Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity
Terminal Elimination Half-Life
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