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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2022-02-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Alzheimer Disease Cognition Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ACD856

Group Type EXPERIMENTAL

ACD856

Intervention Type 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 (fed cohort)

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo oral solution

Interventions

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ACD856

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.

Intervention Type DRUG

Placebo

Placebo oral solution

Intervention Type DRUG

ACD856 (fed cohort)

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes