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

NCT05077501 | Completed Phase 1

• 1 other identifier: D2000CI-002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Cognition Disorder

Keywords

Alzheimer's Disease; Cognition Disorder

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

ACD856

EXPERIMENTAL

Drug: ACD856

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ACD856 DRUG

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.

ACD856

Placebo DRUG

Placebo oral solution

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AlzeCure Pharma: lead

Study Sites (1)

Uppsala University Hospital

Uppsala, Sweden

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognition Disorders

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Johan Sandin, PhD

  AlzeCure Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 14, 2021
• Study Start: September 29, 2021
• Primary Completion: May 16, 2022
• Study Completion: May 23, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)