Clinical trial NCT04149860: Study With Lu AF87908 in Healthy Participants and Participants With Alzheimer's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Alzheimer Disease
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2019-11-04
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants with Treatment Emergent Adverse Events
timeFrame: From Day 0 to Day 84
measure: AUC(0-t) of Lu AF87908
timeFrame: From Day 0 to Day 84
measure: Cmax of Lu AF87908
timeFrame: From Day 0 to Day 84
measure: Tmax Lu AF87908
timeFrame: From Day 0 to Day 84
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: PAREXEL International
state: California
city: Hollywood
country: United States
facility: Research Center of America
state: Florida
city: Miami
country: United States
facility: Panax Clinical Research
state: Florida
city: Decatur
country: United States
facility: iResearch Atlanta LLC
state: Georgia
city: Princeton
country: United States
facility: Princeton Medical Institute
state: New Jersey
city: New York
country: United States
facility: Clinilabs, Inc.
state: New York
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: