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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Alzheimer Disease
• Intervention / Treatment: Drug: Lu AF87908; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Email contact via H. Lundbeck A/S; Phone Number: +45 36301311; Email: LundbeckClinicalTrials@Lundbeck.com

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • PAREXEL International
  • Florida
    • Hollywood, Florida, United States, 33024
      • Research Center of America
    • Miami, Florida, United States, 33014
      • Panax Clinical Research
  • Georgia
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta LLC
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Princeton Medical Institute
  • New York
    • New York, New York, United States, 10019
      • Clinilabs, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Lu AF87908; Lu AF87908 concentrate for solution for intravenous (IV) infusion; Drug: Placebo; Concentrate for solution for IV infusion
Experimental: 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.	Drug: Lu AF87908; Lu AF87908 concentrate for solution for intravenous (IV) infusion; Drug: Placebo; Concentrate for solution for IV infusion
Experimental: 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.	Drug: Lu AF87908; Lu AF87908 concentrate for solution for intravenous (IV) infusion; Drug: Placebo; Concentrate for solution for IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
AUC(0-t) of Lu AF87908	Area under the plasma concentration curve for Lu AF87908	From Day 0 to Day 84
Cmax of Lu AF87908	Maximum observed plasma concentration for Lu AF87908	From Day 0 to Day 84
Tmax Lu AF87908	Nominal time of occurrence of Cmax of Lu AF97908 in plasma	From Day 0 to Day 84

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S
• Investigators: Study Director: Email contact via H. Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.com

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2019
• Primary Completion (Actual): July 19, 2023
• Study Completion (Actual): July 19, 2023

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: November 1, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 18146A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No