Study With Lu AF87908 in Healthy Participants and Participants With Alzheimer's Disease

Healthy Clinical Trial

Official title:

Interventional, Randomized, Double-blind, Placebo-controlled, Single-ascending-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Lu AF87908 in Healthy Subjects and Patients With Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04149860
• Other study ID #: 18146A
• Status: Completed
• Phase: Phase 1
• Start date: September 27, 2019
• Est. completion date: July 19, 2023

Study information

• Verified date: August 2023
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the safety of a single dose of Lu AF87908, how well it is tolerated and what the body does to the drug in healthy participants and participants with Alzheimer's disease.

Description:

The study will be divided into three parts: Part A, Part B and Part C. Part A consists of up to 6 sequential cohorts (Cohorts A1 to A6): -Cohorts A1 to A6: 8 healthy participants per cohort (aiming for an equal number of men and women): 6 randomized to Lu AF87908 and 2 randomized to placebo. Part B consists of up to 3 sequential cohorts (Cohorts B1 to B3): -Cohorts B1 to B3: 4 Japanese and 4 Chinese healthy participants per cohort: 6 participants randomized to Lu AF87908 and 2 participants randomized to placebo. Part C consists of 2 sequential cohorts (Cohorts C1 and C4): -Cohort C1 will consist of 6 participants with Alzheimer's disease with 3:1 randomization scheme for active: placebo. Cohort C4 will consist of up to 8 participants. Cohort C4 participants will be randomized based on the randomization scheme from Cohort C1.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: July 19, 2023
• Est. primary completion date: July 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria Healthy Participants: -Men and women =18 and =65 years of age with a body mass index (BMI) =18 and =32 kilograms (kg)/square meter (m^2) and a minimum weight of 50 kg.

Participants with Alzheimer's disease:

• Men and women with a clinical diagnosis of Alzheimer's disease, Stages 3-4 according to the FDA guidelines.
• Mini-Mental State Examination (MMSE) of 15-30.
• Clinical Dementia Scale (CDR) global score up to and including 2.0.
• Confirmed or determined (via amyloid positron emission tomography [PET] scan) to be amyloid positive.
• If on FDA approved Alzheimer's disease medication, the treatment has been stable for 4 months prior to Day 1. -=50 years of age.
• BMI =18 and =40 kg/m^2 and a minimum weight of 50 kg.

Exclusion criteria:

• Clinically relevant structural brain abnormality as assessed using magnetic resonance imaging (MRI).
• Any past or current treatment with an anti-Abeta or anti-tau active vaccine.
• Any past or current treatment with a monoclonal anti-tau antibody or a tau anti-sense oligomer within the last 6 months.
• Treatment with covid-19, influenza or pneumonia vaccine within the last 30 days prior to dosing of investigational medicinal product (IMP). Other eligibility criteria may apply.

Related Conditions & MeSH terms

• Alzheimer Disease
• Healthy

Intervention

Drug:
• Lu AF87908
Lu AF87908 concentrate for solution for intravenous (IV) infusion
• Placebo
Concentrate for solution for IV infusion

Locations

Country	Name	City	State
United States	iResearch Atlanta LLC	Decatur	Georgia
United States	PAREXEL International	Glendale	California
United States	Research Center of America	Hollywood	Florida
United States	Panax Clinical Research	Miami	Florida
United States	Clinilabs, Inc.	New York	New York
United States	Princeton Medical Institute	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Treatment Emergent Adverse Events	Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination)	From Day 0 to Day 84
Primary	AUC(0-t) of Lu AF87908	Area under the plasma concentration curve for Lu AF87908	From Day 0 to Day 84
Primary	Cmax of Lu AF87908	Maximum observed plasma concentration for Lu AF87908	From Day 0 to Day 84
Primary	Tmax Lu AF87908	Nominal time of occurrence of Cmax of Lu AF97908 in plasma	From Day 0 to Day 84