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

NCT05077631 | Completed Phase 1

• 1 other identifier: D2000CI-001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Cognition Disorder

Keywords

Cognition Disorder; Alzheimer's Disease

Outcome Measures

Primary Outcomes (5)

• Frequency of adverse events (AEs)

  Number of subjects and percentage of subjects with AEs

  8 days

• Clinically significant changes in 12-lead ECGs

  Number of subjects and percentage of subjects with clinically significant changes in 12-lead ECGs

  8 days

• 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

• 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

• Clinically significant changes in physical examinations

  Number of subjects and percentage of subjects with clinically significant changes in physical examinations

  8 days

Study Arms (2)

ACD856

EXPERIMENTAL

Drug: ACD856; Drug: ACD856 (fed cohort)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ACD856 DRUG

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.

ACD856

Placebo DRUG

Placebo oral solution

Placebo

ACD856 (fed cohort) DRUG

Single oral dose of ACD856 in fed state of either dose 4 or dose 5.

ACD856

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AlzeCure Pharma: lead

Study Sites (1)

Uppsala University Hospital

Uppsala, Sweden

Location

Related Publications (1)

• Nilsson B, Bylund J, Halldin MM, Rother M, Rein-Hedin E, Onnestam K, Segerdahl M. ACD856, a novel positive allosteric modulator of Trk receptors, single ascending doses in healthy subjects: Safety and pharmacokinetics. Eur J Clin Pharmacol. 2024 May;80(5):717-727. doi: 10.1007/s00228-024-03645-1. Epub 2024 Feb 14.

  PMID: 38353689 DERIVED

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

  AlzeCure Pharma

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: October 14, 2021
• Study Start: February 15, 2021
• Primary Completion: February 22, 2022
• Study Completion: February 22, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)