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

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease; Cognition Disorder
• Intervention / Treatment: Drug: Placebo; Drug: ACD856

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden
    • Uppsala University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Placebo oral solution
EXPERIMENTAL: ACD856	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of adverse events (AEs)	Number and percentage of subjects with adverse events (AEs).	16 days
Clinically significant changes in 12-lead ECGs	Number of subjects and percentage of subjects with clinically significant changes in 12-lead ECGs	16 days
Clinically significant changes in vital signs	Number of subjects and percentage of subjects with clinically significant changes in vital signs or stool frequency	16 days
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.	16 days
Clinically significant changes in physical examinations	Number of subjects and percentage of subjects with clinically significant changes in physical examinations	16 days
GAD-7	Change from baseline of GAD-7	16 days
PHQ-9	Change from baseline of PHQ-9	16 days
C-SSRS	Change from baseline of C-SSRS	16 days
Prolactin	Change from baseline of prolactin levels	10 days

Collaborators and Investigators

• Sponsor: AlzeCure Pharma
• Investigators: Study Director: Johan Sandin, PhD, AlzeCure Pharma

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 29, 2021
• Primary Completion (ACTUAL): May 16, 2022
• Study Completion (ACTUAL): May 23, 2022

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: October 1, 2021
• First Posted (ACTUAL): October 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Alzheimer's Disease; Cognition Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Cognition Disorders
• Other Study ID Numbers: D2000CI-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No