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

NCT ID: NCT05077501

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-29
• Study Completion Date: 2022-05-23

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ACD856

Group Type: EXPERIMENTAL

ACD856

Intervention Type: 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.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo oral solution

Interventions

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.

Intervention Type: DRUG

Placebo

Placebo oral solution

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AlzeCure Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johan Sandin, PhD

Role: STUDY_DIRECTOR

AlzeCure Pharma

Locations

Uppsala University Hospital

Uppsala, , Sweden

Countries

Sweden

Other Identifiers

D2000CI-002

Identifier Type: -

Identifier Source: org_study_id