NCT04901078

A Phase 1 Study Investigating the Safety, Tolerability and Pharmacokinetics of KNX100 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Kinoxis Therapeutics Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is an adaptive, Phase 1, first-in-human (FIH), single treatment, double blind, placebo controlled, randomized, single and multiple ascending dose study of KNX100 administered to healthy volunteers. Approximately 64 male and female healthy subjects will be enrolled into this study. Healthy subjects who meet all the eligibility criteria will be randomly assigned to Cohorts 1-5 for the Single Ascending Dose and Cohorts 1-3 for the Multiple Ascending Dose. Each cohort will evaluate 8 subjects; 6 subjects will receive KNX100 (study drug) and 2 subjects will receive placebo. Each cohort will be enrolled sequentially, and dose escalation decisions will be made according to protocol by the Cohort Review Committee (CRC) consisting of the investigators and medical monitor. Subjects and clinical staff will be blinded to therapy assignment. KNX100 will be provided in capsule form as 5, 25 and 100 mg capsules for oral administration and the dose range will be 5 to 50mg.

Conditions

• Healthy Volunteer Study
• Opioid-use Disorder

Interventions

Type	Name	Description
DRUG	KNX100	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.

Timeline

• Start date: 2022-04-07
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2021-05-25
• Last updated: 2025-01-06
• Results posted: 2025-01-06

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study