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

• Sponsor: H. Lundbeck A/S (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04149860
• Collaborator: (none)
• Enrollment: 88
• Locations: 6
• Arms: 3
• Anticipated Duration (Months): 37.8
• Patients Per Site: 14.7
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy; Alzheimer Disease	Drug: Lu AF87908; Drug: Placebo	Phase 1

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):

-Cohorts C1 and C4: 8 participants with Alzheimer's disease per cohort: 6 randomized to Lu AF87908 and 2 randomized to placebo.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Sep 27, 2019
• Anticipated Primary Completion Date: Nov 22, 2022
• Anticipated Study Completion Date: Nov 22, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of Participants with Treatment Emergent Adverse Events [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 [From Day 0 to Day 84]

   Area under the plasma concentration curve for Lu AF87908

3. Cmax of Lu AF87908 [From Day 0 to Day 84]

   Maximum observed plasma concentration for Lu AF87908

4. Tmax Lu AF87908 [From Day 0 to Day 84]

   Nominal time of occurrence of Cmax of Lu AF97908 in plasma

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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, AND

• 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 ≤34 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PAREXEL International	Glendale	California	United States	91206
2	Research Center of America	Hollywood	Florida	United States	33024
3	Panax Clinical Research	Miami	Florida	United States	33014
4	iResearch Atlanta LLC	Decatur	Georgia	United States	30030
5	Princeton Medical Institute	Princeton	New Jersey	United States	08540
6	Clinilabs, Inc.	New York	New York	United States	10019

Sponsors and Collaborators

• H. Lundbeck A/S

Investigators

• Study Director: Email contact via H. Lundbeck A/S, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: H. Lundbeck A/S
• ClinicalTrials.gov Identifier: NCT04149860
• Other Study ID Numbers: 18146A
• First Posted: Nov 4, 2019
• Last Update Posted: Aug 10, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alzheimer Disease

Study Results

No Results Posted as of Aug 10, 2022