Clinical trial NCT05077501: Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of ACD856
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Cognition Disorder
Keywords: Alzheimer's Disease
Cognition Disorder
Lead sponsor: AlzeCure Pharma
Sponsor class: INDUSTRY
First posted: 2021-10-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Frequency of adverse events (AEs)
timeFrame: 16 days
measure: Clinically significant changes in 12-lead ECGs
timeFrame: 16 days
measure: Clinically significant changes in vital signs
timeFrame: 16 days
measure: Clinically significant changes in hematology, clinical chemistry, coagulation and/or urinalysis parameters
timeFrame: 16 days
measure: Clinically significant changes in physical examinations
timeFrame: 16 days
measure: GAD-7
timeFrame: 16 days
measure: PHQ-9
timeFrame: 16 days
measure: C-SSRS
timeFrame: 16 days
measure: Prolactin
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: AlzeCure Pharma
name: Johan Sandin, PhD
role: STUDY_DIRECTOR
References: