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

Phase 1

Completed

• Conditions: Cognition Disorder; Alzheimer Disease
• Interventions: Drug: ACD856; Drug: Placebo

• Registration Number: NCT05077501
• Lead Sponsor: AlzeCure Pharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-29
• Study First Submitted: 2021-10-01
• Study First Submitted QC: 2021-10-01
• Study First Posted: 2021-10-14
• Primary Completion: 2022-05-16
• Study Completion: 2022-05-23
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Signed and dated informed consent prior to any study-mandated procedure.
• Willing and able to comply with study requirements.
• Healthy male or female adults of non-childbearing potential aged ≥ 18 and ≤ 65 years at screening.
• Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 at screening.
• Only subjects of non-childbearing potential may be included in the study. Male subjects with partners of childbearing potential must be willing to use condoms, be vasectomised or practice sexual abstinence to prevent pregnancy and drug exposure of a partner, as well as 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

• Any exposure to ACD856 in the past.
• Treatment with another investigational drug within 3 months prior to or during the study.
• 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 subjects who use nicotine products.
• History of alcohol abuse or excessive intake of alcohol.
• History of, or current use of, anabolic steroids.
• Excessive caffeine consumption.
• Plasma donation or blood donation prior to screening.
• Any planned night shift work within the duration of the study, from 48 h prior to randomisation until follow-up.
• Any planned major surgery within the duration of the study.
• Evidence of an active infection that requires treatment with antibiotics within 2 weeks of planned dosing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACD856	ACD856	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Frequency of adverse events (AEs)	16 days	Number and percentage of subjects with adverse events (AEs).
Clinically significant changes in 12-lead ECGs	16 days	Number of subjects and percentage of subjects with clinically significant changes in 12-lead ECGs
Clinically significant changes in vital signs	16 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	16 days	Number of subjects and percentage of subjects with clinically significant changes in any safety laboratory assessments.
Clinically significant changes in physical examinations	16 days	Number of subjects and percentage of subjects with clinically significant changes in physical examinations
GAD-7	16 days	Change from baseline of GAD-7
PHQ-9	16 days	Change from baseline of PHQ-9
C-SSRS	16 days	Change from baseline of C-SSRS
Prolactin	10 days	Change from baseline of prolactin levels

Trial Locations

Locations (1)

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden