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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04149860
Other study ID # 18146A
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 27, 2019
Est. completion date July 19, 2023

Study information

Verified date August 2023
Source H. Lundbeck A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date July 19, 2023
Est. primary completion date July 19, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Lu AF87908
Lu AF87908 concentrate for solution for intravenous (IV) infusion
Placebo
Concentrate for solution for IV infusion

Locations

Country Name City State
United States iResearch Atlanta LLC Decatur Georgia
United States PAREXEL International Glendale California
United States Research Center of America Hollywood Florida
United States Panax Clinical Research Miami Florida
United States Clinilabs, Inc. New York New York
United States Princeton Medical Institute Princeton New Jersey

Sponsors (1)

Lead Sponsor Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

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