Study Evaluating the Pharmacokinetics of a Single Microdose of ACD856

• Sponsor: AlzeCure Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05783830
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Actual Duration (Months): 3.2
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

This is a Phase 0, open-label, non-controlled, single-centre study designed to evaluate the pharmacokinetics (PK) and safety and tolerability of a single, bolus intravenous (iv) injection of a microdose of ACD856 in healthy subjects.

Condition or Disease	Intervention/Treatment	Phase
Cognition Disorder; Alzheimer Disease	Drug: ACD856	Early Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 0, Open-label, Non-controlled Study to Evaluate the Pharmacokinetics of a Single Intravenous Microdose of ACD856 in Healthy Volunteers
• Actual Study Start Date: Jan 13, 2020
• Actual Primary Completion Date: Apr 18, 2020
• Actual Study Completion Date: Apr 18, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ACD856	Drug: ACD856; IV injection 100 mcg

Outcome Measures

Primary Outcome Measures

1. Area under the plasma concentration vs time curve from time zero extrapolated to infinity [24 hours]

   a pharmacokinetic measure of the amount of study medication present in the blood

2. AUC from time zero to time of last quantifiable analyte concentration [96 hours]

   a pharmacokinetic measure of the amount of study medication present in the blood

3. Half-life associated with terminal slope of a semi-logarithmic concentration-time curve [24 hours]

   a pharmacokinetic measure of the time it takes for the study drug to be eliminated from the blood

4. Total body clearance following iv administration [24 hours]

   a pharmacokinetic measure of the time it takes for the study drug to be eliminated from the blood

5. Volume of distribution following iv administration [24 hours]

   a theoretical estimate of how much of the study drug that the body may contain

Secondary Outcome Measures

1. Number of subjects with adverse events [5 days]

   how many participants have reported a drug related advers event

2. Number of subjects with clinically significant changes in vital signs [5 days]

   how many participants have had any clinically significant changes in vital signs

3. Number of subjects with clinically significant changes in 12-lead electrocardiograms (ECGs) [5 days]

   how many participants have had study drug related changes to cardiac function

4. Number of subjects with clinically significant changes in haematology and clinical chemistry and/or urinalysis [5 days]

   how many participants have had study drug related changes in laboratory test analyses

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy males aged >18 and <65 years.

• Signed and dated informed consent prior to any study-mandated procedure

• Willing and able to comply with study requirements.

• BMI >18.0 and <30.0 kg/m^2

• Male subjects must be willing to use condom or be vasectomised 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 normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.

Exclusion Criteria:

• History of any clinically significant disease or disorder which may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.

• Any planned major surgery within the duration of the study.

• Clinically relevant findings in laboratory parameters, ECG or vital signs at screening

• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity

• Regular use of any prescribed or non-prescribed medication

• Planned treatment or treatment with another investigational drug within 3 months

• Current smokers or users of nicotine products.

• Positive screen for drugs of abuse or alcohol at screening

• 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 during the 3 months prior to screening.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uppsala University Hospital	Uppsala		Sweden

Sponsors and Collaborators

• AlzeCure Pharma

Investigators

• Study Director: Johan Sandin, AlzeCure Pharma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AlzeCure Pharma
• ClinicalTrials.gov Identifier: NCT05783830
• Other Study ID Numbers: D2000C0-001
• First Posted: Mar 24, 2023
• Last Update Posted: Mar 24, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by AlzeCure Pharma: Cognition Disorder; Alzheimer's Disease
• Additional relevant MeSH terms: Alzheimer Disease; Cognition Disorders

Study Results

No Results Posted as of Mar 24, 2023