At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 16 enrolled
Drug / intervention
AIO-001drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open-Label, Single Dose, Parallel Group, Phase 1 Study in Healthy Volunteers Evaluating Safety, Tolerability, Pharmacokinetics, and Immunogenicity AIO-001 Administered by Injections
In Brief
A Phase 1 clinical trial evaluating AIO-001 for Respiratory Disease. Completed, enrolled 16 participants across 1 site.
Detailed Summary
This goal of the open-label single dose study is to evaluate and compare the safety, tolerability, pharmacokinetic (PK), and immunogenicity of AIO-001 using two different formulations in 16 healthy volunteers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Disease
CountriesAustralia
CollaboratorsAiolos Bio, Inc.
Timeline
Phase 1CompletedFinished
202420252026
Enrollment StartNov 2023
First PostedDec 2023
Primary CompletionJul 2024
TodayJul 2026
First PostedDec 14, 2023
Enrollment StartNov 21, 2023
Primary CompletionJul 15, 2024
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 2.6 years ago
Interventions
AIO-001drug
AIO-001 Solution for SC injection.