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Completed

NCT Number: NCT04149860

Study With Lu AF87908 in Healthy Participants and Participants 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PAREXEL International, Glendale, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lu AF87908

Drug

Lu AF87908 concentrate for solution for intravenous (IV) infusion

Placebo

Drug

Concentrate for solution for IV infusion

Primary outcomes

  1. Number of Participants with Treatment Emergent Adverse Events

    Time frame: From Day 0 to Day 84

    Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination)

  2. AUC(0-t) of Lu AF87908

    Time frame: From Day 0 to Day 84

    Area under the plasma concentration curve for Lu AF87908

  3. Cmax of Lu AF87908

    Time frame: From Day 0 to Day 84

    Maximum observed plasma concentration for Lu AF87908

  4. Tmax Lu AF87908

    Time frame: From Day 0 to Day 84

    Nominal time of occurrence of Cmax of Lu AF97908 in plasma

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 4, 2019
Registry last updated
Aug 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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