NCT04751539

A Dose-escalation Study of AND017 in Healthy Subjects

A Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AND017 Following Oral Single and Multiple Dose Administration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Kind Pharmaceuticals LLC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a phase I, randomized, double-blind, placebo-controlled, dose-escalation study in healthy subjects to evaluate safety, tolerability, PKs and PDs of AND017 following oral single and multiple dose administration.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	AND017 single dose	AND017 administrated as oral single-dose on Day 1 in Part A
DRUG	AND017 multiple dose	AND017 administrated once daily from Day 1 to Day 10 in Part B
DRUG	Placebo	Placebo administrated once on Day 1 in Part A or daily from Day 1 to Day 10 in Part B

Timeline

• Start date: 2018-07-16
• Primary completion: 2019-02-11
• Completion: 2019-02-11
• First posted: 2021-02-12
• Last updated: 2021-05-11

Locations

1 site across 1 country: Australia