At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 57 enrolled
Drug / intervention
KNX100drug
Likely dose
KNX100 100 mgfrom 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.
A Phase 1 Study Investigating the Safety, Tolerability and Pharmacokinetics of KNX100 in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating KNX100 for Healthy Volunteer Study and Opioid-use Disorder. Completed, enrolled 57 participants across 1 site.
Detailed Summary
The primary objectives of this study are to evaluate the safety and tolerability of KNX100 administered orally as a single and multiple ascending doses in healthy volunteers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteer Study, Opioid-use Disorder
CountriesAustralia
CollaboratorsNational Institute on Drug Abuse (NIDA)
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedMay 2021
Enrollment StartApr 2022
Primary CompletionSep 2023
TodayJul 2026
First PostedMay 25, 2021
Enrollment StartApr 7, 2022
Primary CompletionSep 30, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.1 years ago
Interventions
KNX100drug
KNX100 will be provided in capsule form as 5, 25 and 100 mg capsules for oral administration. Study drug will be encapsulated in hydroxypropyl methylcellulose (HPMC) dark green opaque size 0 capsules and packaged in 100 mL high density polyethylene (HDPE) bottles with polypropylene (PP) twist-off closures.