NCT05077631

Study to Evaluate the Effects of Single Ascending Oral Doses of ACD856 on Safety, Tolerability and Pharmacokinetics

A Phase I, Double-Blind, Placebo-controlled, Randomized Study to Evaluate the Effects of Single Ascending Oral Doses of ACD856 on Safety, Tolerability and Pharmacokinetics in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: AlzeCure Pharma · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The SAD design of the study is based on the aim to study safety, tolerability and PK 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	Single oral doses of ACD856 administered in a fasted state in escalation schedule of dose 1, dose 2, dose 3, dose 4, dose 5, dose 6 and dose 7. The escalation schedule may be adapted based on evaluation by internal Safety Review Committee.
DRUG	Placebo	Placebo oral solution
DRUG	ACD856 (fed cohort)	Single oral dose of ACD856 in fed state of either dose 4 or dose 5.

Timeline

• Start date: 2021-02-15
• Primary completion: 2022-02-22
• Completion: 2022-02-22
• First posted: 2021-10-14
• Last updated: 2022-07-20

Locations

1 site across 1 country: Sweden