NCT05077501

Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of ACD856

A Prospective, Phase I, Double-blind, Parallel-group, Placebo-controlled, Randomised Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Oral Doses of ACD856 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: AlzeCure Pharma · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The multiple ascending dose (MAD) design of the study is based on the aim to study safety, tolerability, PK and pharmacodynamics of selected doses of ACD856 in a limited number of healthy volunteers. ACD856 will be administered orally.

Conditions

• Alzheimer Disease
• Cognition Disorder

Interventions

Type	Name	Description
DRUG	ACD856	Multiple daily oral doses of ACD856 will be administered for 7 days in an escalation scheme of dose 1, dose 2 and dose 3. The escalation schedule may be adapted based on evaluation by the internal Safety Review Committee.
DRUG	Placebo	Placebo oral solution

Timeline

• Start date: 2021-09-29
• Primary completion: 2022-05-16
• Completion: 2022-05-23
• First posted: 2021-10-14
• Last updated: 2022-07-20

Locations

1 site across 1 country: Sweden