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

Autosomal Dominant Polycystic Kidney Clinical Trial

Official title:
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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04908462
Study type Interventional
Source AceLink Therapeutics, Inc.
Contact
Status Completed
Phase Phase 1
Start date June 8, 2021
Completion date June 20, 2022
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