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

Primary Purpose

Healthy, Alzheimer Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lu AF87908
Placebo
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 20-30
  • Clinical Dementia Scale (CDR) global score of 0.5 or 1.0.
  • 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.

Sites / Locations

  • PAREXEL International
  • Research Center of America
  • Panax Clinical Research
  • iResearch Atlanta LLC
  • Princeton Medical Institute
  • Clinilabs, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Part A: Lu AF87908 or Placebo

Part B: Lu AF87908 or Placebo

Part C: Lu AF87908 or Placebo

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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)
AUC(0-t) of Lu AF87908
Area under the plasma concentration curve for Lu AF87908
Cmax of Lu AF87908
Maximum observed plasma concentration for Lu AF87908
Tmax Lu AF87908
Nominal time of occurrence of Cmax of Lu AF97908 in plasma

Secondary Outcome Measures

Full Information

First Posted
October 31, 2019
Last Updated
August 3, 2023
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT04149860
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 27, 2019 (Actual)
Primary Completion Date
July 19, 2023 (Actual)
Study Completion Date
July 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A: Lu AF87908 or Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Part B: Lu AF87908 or Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Part C: Lu AF87908 or Placebo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lu AF87908
Intervention Description
Lu AF87908 concentrate for solution for intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Concentrate for solution for IV infusion
Primary Outcome Measure Information:
Title
Number of Participants with Treatment Emergent Adverse Events
Description
Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination)
Time Frame
From Day 0 to Day 84
Title
AUC(0-t) of Lu AF87908
Description
Area under the plasma concentration curve for Lu AF87908
Time Frame
From Day 0 to Day 84
Title
Cmax of Lu AF87908
Description
Maximum observed plasma concentration for Lu AF87908
Time Frame
From Day 0 to Day 84
Title
Tmax Lu AF87908
Description
Nominal time of occurrence of Cmax of Lu AF97908 in plasma
Time Frame
From Day 0 to Day 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
PAREXEL International
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Research Center of America
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Panax Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
iResearch Atlanta LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Princeton Medical Institute
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Clinilabs, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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