This is a first-in-human, randomized, double-blind, placebo-controlled, Phase 1 study of AER-01 (solution for inhalation, delivered via nebulizer) to assess the safety, tolerability and PK of AER-01. The study will be conducted in 2 parts: a single ascending dose (SAD) part in HVs (Part A) and a 7-day multiple ascending dose (MAD) part in HVs(Part B).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
72
CMAX
Adelaide, Australia
RECRUITINGScientia Clinical Research
Sydney, Australia
RECRUITINGNumber of participants with treatment-related adverse events as assessed by CTCAE v5.0
Will be summarized by cohort, preferred term (PT), system organ class (SOC), severity, and relationship to IP.
Time frame: Baseline to Day 2 (Part A), Baseline to Day 8 (Part B)
Maximum Plasma Concentration [Cmax]
Will be summarized using descriptive statistics by cohort, timepoint, and dose
Time frame: Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)
Time to maximum concentration [Tmax]
Will be summarized using descriptive statistics by cohort, timepoint, and dose
Time frame: Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)
Area under the drug concentration-time curve from time 0 (time of dosing) extrapolated to infinity [AUC 0-inf]
Will be summarized using descriptive statistics by cohort, timepoint, and dose
Time frame: Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)
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