HealthyPhase 1NCT03611569
Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease
A Phase 1 study testing Lu AF82422 in people with Healthy and Parkinson Disease, run by H. Lundbeck A/S at 4 sites in United States.
Trial summary
The purpose of this study is to investigate the safety of a single dose of Lu AF82422, how well it is tolerated, how the drug effects the body and what the body does to the drug in healthy non-Japanese and Japanese subjects and in patients with Parkinson's disease Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Parkinson Disease
- What is being tested?
- Lu AF82422
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 Jul 2018to 26 Jul 2021
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects:
- Men and women ≥18 and ≤55 years of age with a body mass index (BMI) ≥18 and ≤32 kg/m2 (non-Japanese subjects) and ≥18 and ≤28 kg/m2 (Japanese subjects)
- Patients with Parkinson's disease:
- Men and women with a clinical diagnosis of idiopathic Parkinson's disease, Hoehn and Yahn (H\&Y, stage 1-3)
- For a minimum of three months prior to enrolment, Parkinson's disease symptoms have been stable and is anticipated to be stable during the study duration as judged by the PI
- If on Parkinson's disease treatment the dose must be stable for a minimum of three months prior to enrolment and is anticipated to be stable during the study duration as judged by the PI
- ≥40 and ≤80 years of age
- BMI ≥18 and ≤35 kg/m2
Who cannot join
- Atypical Parkinsonism
- Clinically relevant structural brain abnormality, as assessed using MRI
- Mild cognitive impairment, measured as a Montreal cognitive assessment (MoCA) score =<21
- Any past or current treatment with an active vaccine targeting alpha-synuclein
- Any past or current treatment with a monoclonal antibody within the last 12 months
- Other in- and exclusion criteria may apply.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Parexel, Early Phase Clinical Unit (EPCU), Harbor Hospital
Baltimore, Maryland, 21225
California Clinical Trials Medical Group (CCTMG)
Glendale, California, 91206
Reserach Center of America
Hollywood, Florida, 33024
PPD
Orlando, Florida, 32806
About this study
Official title: Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single-ascending-dose Study Investigating the Safety, Tolerability and Pharmacokinetic and Pharmacodynamic Properties of Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease
The purpose of this study is to investigate the safety of a single dose of Lu AF82422, how well it is tolerated, how the drug effects the body and what the body does to the drug in healthy non-Japanese and Japanese subjects and in patients with Parkinson's disease
- Conditions
- Healthy, Parkinson Disease
- Being tested
- Lu AF82422, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AF82422Drug
Lu AF82422 - concentrate for solution for infusion; vials containing 50mg/ml, single dose
PlaceboDrug
placebo - concentrate for solution for infusion, single dose
| Study group | Role | What they receive |
|---|---|---|
| Lu AF82422 | Experimental | Part A:
Cohort A1, A2, and A3: 24 healthy subjects, with 8 subjects per cohort (aiming for an equal number of men and women) Cohort A4,A5,A6: 36 healthy subjects, with 6 non-Japanese subjects and 6 Japanese subjects per cohort (aiming for an equal number of men and women)
Part B:
Cohort B1, B2, B3: 24 patients with Parkinson's disease Receives: Drug: Lu AF82422 |
| Placebo | Placebo comparator | Part A:
Cohort A1, A2, and A3: 24 healthy subjects, with 8 subjects per cohort (aiming for an equal number of men and women) Cohort A4,A5,A6: 36 healthy subjects, with 6 non-Japanese subjects and 6 Japanese subjects per cohort (aiming for an equal number of men and women)
Part B:
Cohort B1, B2, B3: 24 patients with Parkinson's disease Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, blood closure time and ECG parameters)
Measured: From dosing to Day 84
Secondary outcomes (3)
AUC 0-t
Area under the Lu AF82422 plasma concentration curve from zero to time t
Measured: From dosing to Day 84
Cmax
Maximum observed plasma concentration of Lu AF82422
Measured: From dosing to Day 84
CL
Clearance of Lu AF82422
Measured: From dosing 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 posted2 Aug 2018
- Study start25 Jul 2018
- Primary completion26 Jul 2021
- Study completion26 Jul 2021
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
- Model description
- Cohort
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 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
- NCT03611569
- Sponsor's protocol ID
- 17699A
- Status last verified
- Oct 2021
- First submitted
- 26 Jul 2018
- Last updated
- 12 Oct 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single-ascending-dose Study Investigating the Safety, Tolerability and Pharmacokinetic and Pharmacodynamic Properties of Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03611569
- Acronym / sponsor ID
- 17699A
- Conditions
- Healthy, Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 26 Jul 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 2 Aug 2018 (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 AF82422, how well it is tolerated, how the drug effects the body and what the body does to the drug in healthy non-Japanese and Japanese subjects and in patients with Parkinson's disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Cohort
| Arm | Type | Receives |
|---|---|---|
| Lu AF82422 | Experimental | Drug: Lu AF82422Part A: Cohort A1, A2, and A3: 24 healthy subjects, with 8 subjects per cohort (aiming for an equal number of men and women) Cohort A4,A5,A6: 36 healthy subjects, with 6 non-Japanese subjects and 6 Japanese subjects per cohort (aiming for an equal number of men and women) Part B: Cohort B1, B2, B3: 24 patients with Parkinson's disease |
| Placebo | Placebo comparator | Drug: PlaceboPart A: Cohort A1, A2, and A3: 24 healthy subjects, with 8 subjects per cohort (aiming for an equal number of men and women) Cohort A4,A5,A6: 36 healthy subjects, with 6 non-Japanese subjects and 6 Japanese subjects per cohort (aiming for an equal number of men and women) Part B: Cohort B1, B2, B3: 24 patients with Parkinson's disease |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women ≥18 and ≤55 years of age with a body mass index (BMI) ≥18 and ≤32 kg/m2 (non-Japanese subjects) and ≥18 and ≤28 kg/m2 (Japanese subjects)
- Men and women with a clinical diagnosis of idiopathic Parkinson's disease, Hoehn and Yahn (H\&Y, stage 1-3)
- For a minimum of three months prior to enrolment, Parkinson's disease symptoms have been stable and is anticipated to be stable during the study duration as judged by the PI
- If on Parkinson's disease treatment the dose must be stable for a minimum of three months prior to enrolment and is anticipated to be stable during the study duration as judged by the PI
- ≥40 and ≤80 years of age
Key exclusion criteria (6 listed)
- Atypical Parkinsonism
- Clinically relevant structural brain abnormality, as assessed using MRI
- Mild cognitive impairment, measured as a Montreal cognitive assessment (MoCA) score =<21
- Any past or current treatment with an active vaccine targeting alpha-synuclein
- Any past or current treatment with a monoclonal antibody within the last 12 months
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 AF82422Lu AF82422 - concentrate for solution for infusion; vials containing 50mg/ml, single dose | Drug | Lu AF82422 |
| Placeboplacebo - concentrate for solution for infusion, single dose | Drug | Placebo |
Primary outcome
Number of patients with Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: From dosing to Day 84
Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, blood closure time and ECG parameters)
3 secondary outcomes
AUC 0-t
Time frame: From dosing to Day 84
Cmax
Time frame: From dosing to Day 84
CL
Time frame: From dosing to Day 84
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 12 Oct 2021.
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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
4 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 AF82422 in people with Healthy and Parkinson Disease, run by H. Lundbeck A/S at 4 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 8 inclusion and 6 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 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. Some participants in this study may receive a placebo. 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 patients with Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) (time frame: From dosing to Day 84). 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 12 Oct 2021.