MigrainePhase 1NCT04197349
Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman
A Phase 1 study testing ALD1910 and Sumatriptan in people with Migraine, run by H. Lundbeck A/S at 1 site in Australia.
Trial summary
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of ALD1910, a monoclonal antibody, administered by intravenous infusion and subcutaneous injection. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- ALD1910 and Sumatriptan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteAustralia
- Study dates
- 24 Sep 2019to 19 Aug 2020
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female
- All female subjects must have a negative pregnancy test result and subjects to use of adequate contraception for the duration of the study.
- Body Mass Index (BMI) between 18.0 and 30.0 kg/m2, and a total body weight of 50 to 100 kg inclusive.
Who cannot join
- Use of prescription meds, nutritional supplements, OTC medications.
- New or unusually strenuous exercise for the duration of the trial.
- Current or previous drug or alcohol abuse.
- Current, or previous smoker within 12 weeks prior to screening. Causal or social smokers are allowed.
- Previous treatment or clinical trial with a monoclonal antibody 6 months prior to screening.
- Current participation in any clinical research study.
Show all 9Show fewer
- ECG QTcF greater than or equal to 450 msec.
- Greater than 6.4% glycosylated hemoglobin (HgbA1c) at screening
- Fasting blood glucose greater than or equal to 126 mg/dL (7 mmol/L) at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase 1 Study to Determine the Safety, Tolerability, and Pharmacokinetics of ALD1910, a Humanized Anti-Pituitary Adenylate Cyclase Activating Peptide (PACAP) Monoclonal Antibody
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of ALD1910, a monoclonal antibody, administered by intravenous infusion and subcutaneous injection.
Read the detailed description
This is a first-in-humam, randomized, double-blind, placebo-controlled study in a healthy population. Up to 7 single ascending doses (cohorts 1 to 7) will be studied to determine the safety and tolerability of ALD1910. Approximately 96 healthy male and female participants are planned for the study, 64 for Part A and 32 for Part B.
- Conditions
- Migraine
- Being tested
- ALD1910, Sumatriptan
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALD1910Biological
Single Dose IV infusion
SumatriptanBiological
Single dose subcutaneous injection
ALD1910Biological
Single dose subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Part A Cohort 1-8 | Experimental | ALD1910/Placebo; Single Dose IV infusion on Day 1 Receives: Biological: ALD1910 |
| Part B Cohort 9 | Experimental | ALD1910/Placebo+Sumatriptan; Single Dose IV infusion on Day 1 Receives: Biological: ALD1910; Biological: Sumatriptan |
| Part B Cohort 10 | Experimental | ALD1910/Placebo; Single dose subcutaneous injection on Day 1 Receives: Biological: ALD1910 |
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, ECG parameters)
Measured: From dosing to week 20
Secondary outcomes (4)
Area under the serum concentration-time curve (AUC(0-T))
Measured: From dosing to week 20
Peak serum concentration (Cmax)
Measured: From dosing to week 20
Clearance (Cl)
Measured: From dosing to week 20
Immunogenicity
Number of anti-ALD1910 antibodies (ADA) and characterization of anti-ALD1910 ADA positive responses for neutralizing activity
Measured: From dosing to week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start24 Sep 2019
- Primary completion19 Aug 2020
- Study completion19 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alder Biopharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197349
- Sponsor's protocol ID
- ALD1910-CLIN-001
- Other IDs
- 18902A
- Status last verified
- Sep 2020
- First submitted
- 11 Dec 2019
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase 1 Study to Determine the Safety, Tolerability, and Pharmacokinetics of ALD1910, a Humanized Anti-Pituitary Adenylate Cyclase Activating Peptide (PACAP) Monoclonal Antibody
- ClinicalTrials.gov ID
- NCT04197349
- Acronym / sponsor ID
- ALD1910-CLIN-001
- Conditions
- Migraine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Collaborators
- Alder Biopharmaceuticals, Inc.
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 19 Aug 2020 (actual)
- Study completion
- 19 Aug 2020 (actual)
- First posted
- 13 Dec 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 determine the safety, tolerability and pharmacokinetics of ALD1910, a monoclonal antibody, administered by intravenous infusion and subcutaneous injection.
Detailed description
This is a first-in-humam, randomized, double-blind, placebo-controlled study in a healthy population. Up to 7 single ascending doses (cohorts 1 to 7) will be studied to determine the safety and tolerability of ALD1910. Approximately 96 healthy male and female participants are planned for the study, 64 for Part A and 32 for Part B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A Cohort 1-8 | Experimental | Biological: ALD1910ALD1910/Placebo; Single Dose IV infusion on Day 1 |
| Part B Cohort 9 | Experimental | Biological: ALD1910, Biological: SumatriptanALD1910/Placebo+Sumatriptan; Single Dose IV infusion on Day 1 |
| Part B Cohort 10 | Experimental | Biological: ALD1910ALD1910/Placebo; Single dose subcutaneous injection on Day 1 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male or female
- All female subjects must have a negative pregnancy test result and subjects to use of adequate contraception for the duration of the study.
- Body Mass Index (BMI) between 18.0 and 30.0 kg/m2, and a total body weight of 50 to 100 kg inclusive.
Key exclusion criteria (9 listed)
- Use of prescription meds, nutritional supplements, OTC medications.
- New or unusually strenuous exercise for the duration of the trial.
- Current or previous drug or alcohol abuse.
- Current, or previous smoker within 12 weeks prior to screening. Causal or social smokers are allowed.
- Previous treatment or clinical trial with a monoclonal antibody 6 months prior to screening.
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 |
|---|---|---|
| ALD1910Single Dose IV infusion | Biological | Part A Cohort 1-8, Part B Cohort 9 |
| SumatriptanSingle dose subcutaneous injection | Biological | Part B Cohort 9 |
| ALD1910Single dose subcutaneous injection | Biological | Part B Cohort 10 |
Primary outcome
Number of participants with treatment-emergent adverse events
Time frame: From dosing to week 20
Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, ECG parameters)
4 secondary outcomes
Area under the serum concentration-time curve (AUC(0-T))
Time frame: From dosing to week 20
Peak serum concentration (Cmax)
Time frame: From dosing to week 20
Clearance (Cl)
Time frame: From dosing to week 20
Immunogenicity
Time frame: From dosing to week 20
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 23 Sep 2020.
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALD1910 and Sumatriptan in people with Migraine, run by H. Lundbeck A/S at 1 site in Australia.
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 3 inclusion and 9 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 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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 dosing to week 20). 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 23 Sep 2020.