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

Phase 1

Completed

• Conditions: Cognition Disorder; Alzheimer Disease
• Interventions: Drug: Placebo; Drug: ACD856; Drug: ACD856 (fed cohort)

• Registration Number: NCT05077631
• Lead Sponsor: AlzeCure Pharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-15
• Study First Submitted: 2021-04-01
• Study First Submitted QC: 2021-10-01
• Study First Posted: 2021-10-14
• Primary Completion: 2022-02-22
• Study Completion: 2022-02-22
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
ACD856	ACD856	-
ACD856	ACD856 (fed cohort)	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden