HealthyPhase 1NCT04149860
Study With Lu AF87908 in Healthy Participants and Participants With Alzheimer's Disease
A Phase 1 study testing Lu AF87908 in people with Healthy and Alzheimer Disease, run by H. Lundbeck A/S at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Alzheimer Disease
- What is being tested?
- Lu AF87908
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 6 sitesUnited States
- Study dates
- 27 Sep 2019to 19 Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
iResearch Atlanta LLC
Decatur, Georgia, 30030
PAREXEL International
Glendale, California, 91206
Research Center of America
Hollywood, Florida, 33024
Panax Clinical Research
Miami, Florida, 33014
Clinilabs, Inc.
New York, New York, 10019
Princeton Medical Institute
Princeton, New Jersey, 08540
About this study
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
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.
Read the 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.
- Conditions
- Healthy, Alzheimer Disease
- Being tested
- Lu AF87908, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AF87908Drug
Lu AF87908 concentrate for solution for intravenous (IV) infusion
PlaceboDrug
Concentrate for solution for IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Part A: Lu AF87908 or Placebo | Experimental | 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. Receives: Drug: Lu AF87908; Drug: Placebo |
| Part B: Lu AF87908 or Placebo | Experimental | 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. Receives: Drug: Lu AF87908; Drug: Placebo |
| Part C: Lu AF87908 or Placebo | Experimental | 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. Receives: Drug: Lu AF87908; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From Day 0 to Day 84
AUC(0-t) of Lu AF87908
Area under the plasma concentration curve for Lu AF87908
Measured: From Day 0 to Day 84
Cmax of Lu AF87908
Maximum observed plasma concentration for Lu AF87908
Measured: From Day 0 to Day 84
Tmax Lu AF87908
Nominal time of occurrence of Cmax of Lu AF97908 in plasma
Measured: From Day 0 to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start27 Sep 2019
- Primary completion19 Jul 2023
- Study completion19 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@Lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149860
- Sponsor's protocol ID
- 18146A
- Status last verified
- Aug 2023
- First submitted
- 31 Oct 2019
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04149860
- Acronym / sponsor ID
- 18146A
- Conditions
- Healthy, Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 19 Jul 2023 (actual)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A: Lu AF87908 or Placebo | Experimental | Drug: Lu AF87908, Drug: PlaceboParticipants in Cohorts A1 to A6 will receive a single dose of either Lu AF87908 or matching placebo at specific dose levels on Day 1. |
| Part B: Lu AF87908 or Placebo | Experimental | Drug: Lu AF87908, Drug: PlaceboParticipants in Cohorts B1 to B3 will receive a single dose of either Lu AF87908 or matching placebo at specific dose levels on Day 1. |
| Part C: Lu AF87908 or Placebo | Experimental | Drug: Lu AF87908, Drug: PlaceboParticipants in Cohorts C1 and C4 will receive a single dose of either Lu AF87908 or matching placebo at specific dose levels on Day 1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- -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.
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lu AF87908Lu AF87908 concentrate for solution for intravenous (IV) infusion | Drug | Part A: Lu AF87908 or Placebo, Part B: Lu AF87908 or Placebo, Part C: Lu AF87908 or Placebo |
| PlaceboConcentrate for solution for IV infusion | Drug | Part A: Lu AF87908 or Placebo, Part B: Lu AF87908 or Placebo, Part C: Lu AF87908 or Placebo |
Primary outcome
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)
AUC(0-t) of Lu AF87908
Time frame: From Day 0 to Day 84
Area under the plasma concentration curve for Lu AF87908
Cmax of Lu AF87908
Time frame: From Day 0 to Day 84
Maximum observed plasma concentration for Lu AF87908
Tmax Lu AF87908
Time frame: From Day 0 to Day 84
Nominal time of occurrence of Cmax of Lu AF97908 in plasma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@Lundbeck.com
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lu AF87908 in people with Healthy and Alzheimer Disease, run by H. Lundbeck A/S at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment Emergent Adverse Events (time frame: From Day 0 to Day 84). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.