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

NCT ID: NCT04149860

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-27
• Study Completion Date: 2023-07-19

Brief 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.

Detailed 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.

Conditions

Healthy; Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part A: Lu AF87908 or Placebo

Participants in Cohorts A1 to A6 will receive a single dose of either Lu AF87908 or matching placebo at specific dose levels on Day 1.

Group Type: EXPERIMENTAL

Lu AF87908

Intervention Type: DRUG

Lu AF87908 concentrate for solution for intravenous (IV) infusion

Placebo

Intervention Type: DRUG

Concentrate for solution for IV infusion

Part B: Lu AF87908 or Placebo

Participants in Cohorts B1 to B3 will receive a single dose of either Lu AF87908 or matching placebo at specific dose levels on Day 1.

Group Type: EXPERIMENTAL

Lu AF87908

Intervention Type: DRUG

Lu AF87908 concentrate for solution for intravenous (IV) infusion

Placebo

Intervention Type: DRUG

Concentrate for solution for IV infusion

Part C: Lu AF87908 or Placebo

Participants in Cohorts C1 and C4 will receive a single dose of either Lu AF87908 or matching placebo at specific dose levels on Day 1.

Group Type: EXPERIMENTAL

Lu AF87908

Intervention Type: DRUG

Lu AF87908 concentrate for solution for intravenous (IV) infusion

Placebo

Intervention Type: DRUG

Concentrate for solution for IV infusion

Interventions

Lu AF87908

Lu AF87908 concentrate for solution for intravenous (IV) infusion

Intervention Type: DRUG

Placebo

Concentrate for solution for IV infusion

Intervention Type: DRUG

Eligibility Criteria

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.

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

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@Lundbeck.com

Locations

PAREXEL International

Glendale, California, United States

Research Center of America

Hollywood, Florida, United States

Panax Clinical Research

Miami, Florida, United States

iResearch Atlanta LLC

Decatur, Georgia, United States

Princeton Medical Institute

Princeton, New Jersey, United States

Clinilabs, Inc.

New York, New York, United States

Countries

United States

Other Identifiers

18146A

Identifier Type: -

Identifier Source: org_study_id