NCT04908462

To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AL01211 in Healthy Volunteers

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose in Healthy Volunteers and Autosomal Dominant Polycystic Kidney Disease Subjects Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AL01211

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: AceLink Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of Oral AL01211 in healthy volunteers

Detailed description

This study is a Phase 1, first in human (FIH), randomized, double-blind, placebo-controlled study of AL01211 in healthy adult participants The study consists of two parts: Part A will investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AL01211 in a single ascending dose escalation study in approximately 40 healthy adult participants. Part B will investigate the safety and tolerability, pharmacokinetics, and pharmacodynamics of AL01211 in a multiple ascending dose escalation study in approximately 40 healthy adult volunteers.

Conditions

• Autosomal Dominant Polycystic Kidney

Interventions

Type	Name	Description
DRUG	AL01211 or Placebo (Part A)	Five dose groups with doses ranging from 2mg to 60 mg
DRUG	AL01211 or Placebo (Part B)	Five dose groups with doses ranging from 2-60 mg daily. Each separate dose given for 14 days

Timeline

• Start date: 2021-06-08
• Primary completion: 2022-06-20
• Completion: 2022-06-20
• First posted: 2021-06-01
• Last updated: 2022-10-14

Locations

1 site across 1 country: Australia