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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05077631
• Other study ID #: D2000CI-001
• Status: Completed
• Phase: Phase 1
• Start date: February 15, 2021
• Est. completion date: February 22, 2022

Study information

• Verified date: July 2022
• Source: AlzeCure Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 22, 2022
• Est. primary completion date: February 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Signed and dated informed consent prior to any study-mandated procedure.´

• Willing and able to comply with study requirements.

• Healthy males and healthy women of non-childbearing potential aged =18 and <65 years at screening.

• BMI =18.0 and =30.0 kg/m2 at screening.

• Males and females of non-childbearing potential may be included in the study. Male subjects must be willing to use condom or be vasectomized or practice sexual abstinence to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the date of dosing until 3 months after dosing with the IMP.

• Clinically acceptable medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.

Exclusion Criteria:

• Planned treatment or treatment with another investigational drug within 3 months prior to randomization.

• Positive screen for drugs of abuse or a positive alcohol result at screening or admission to the clinic.

• Clinically relevant findings in laboratory parameters, ECG or vital signs at screening

• Current smokers or users of nicotine products.

• History of alcohol abuse or excessive intake of alcohol.

• Presence or history of drug abuse.

• History of, or current use of, anabolic steroids.

• Excessive caffeine consumption.

• Plasma donation within one month of screening or blood donation prior to screening.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognition Disorder
• Cognition Disorders

Intervention

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.
• Placebo
Placebo oral solution
• ACD856 (fed cohort)
Single oral dose of ACD856 in fed state of either dose 4 or dose 5.

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AlzeCure Pharma

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of adverse events (AEs)	Number of subjects and percentage of subjects with AEs	8 days
Primary	Clinically significant changes in 12-lead ECGs	Number of subjects and percentage of subjects with clinically significant changes in 12-lead ECGs	8 days
Primary	Clinically significant changes in vital signs	Number of subjects and percentage of subjects with clinically significant changes in vital signs or stool frequency	8 days
Primary	Clinically significant changes in hematology, clinical chemistry, coagulation and/or urinalysis parameters	Number of subjects and percentage of subjects with clinically significant changes in any safety laboratory assessments.	8 days
Primary	Clinically significant changes in physical examinations	Number of subjects and percentage of subjects with clinically significant changes in physical examinations	8 days