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Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04197349
Recruitment Status : Completed
First Posted : December 13, 2019
Last Update Posted : September 23, 2020
Sponsor:
Collaborator:
Alder Biopharmaceuticals, Inc.
Information provided by (Responsible Party):
H. Lundbeck A/S

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Migraine Biological: ALD1910 Biological: Sumatriptan Phase 1

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 24, 2019
Actual Primary Completion Date : August 19, 2020
Actual Study Completion Date : August 19, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
Drug Information available for: Sumatriptan

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A Cohort 1-8
ALD1910/Placebo; Single Dose IV infusion on Day 1
 Biological: ALD1910
Single Dose IV infusion
Experimental: Part B Cohort 9
ALD1910/Placebo+Sumatriptan; Single Dose IV infusion on Day 1
 Biological: ALD1910
Single Dose IV infusion

Biological: Sumatriptan
Single dose subcutaneous injection
Experimental: Part B Cohort 10
ALD1910/Placebo; Single dose subcutaneous injection on Day 1
 Biological: ALD1910
Single dose subcutaneous injection


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Area under the serum concentration-time curve (AUC(0-T)) [ Time Frame: From dosing to week 20 ]
  2. Peak serum concentration (Cmax) [ Time Frame: From dosing to week 20 ]
  3. Clearance (Cl) [ Time Frame: From dosing to week 20 ]
  4. Immunogenicity [ Time Frame: From dosing to week 20 ]
    Number of anti-ALD1910 antibodies (ADA) and characterization of anti-ALD1910 ADA positive responses for neutralizing activity


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male or female
  2. All female subjects must have a negative pregnancy test result and subjects to use of adequate contraception for the duration of the study.
  3. Body Mass Index (BMI) between 18.0 and 30.0 kg/m2, and a total body weight of 50 to 100 kg inclusive.

Exclusion Criteria:

  1. Use of prescription meds, nutritional supplements, OTC medications.
  2. New or unusually strenuous exercise for the duration of the trial.
  3. Current or previous drug or alcohol abuse.
  4. Current, or previous smoker within 12 weeks prior to screening. Causal or social smokers are allowed.
  5. Previous treatment or clinical trial with a monoclonal antibody 6 months prior to screening.
  6. Current participation in any clinical research study.
  7. ECG QTcF greater than or equal to 450 msec.
  8. Greater than 6.4% glycosylated hemoglobin (HgbA1c) at screening
  9. Fasting blood glucose greater than or equal to 126 mg/dL (7 mmol/L) at screening
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04197349


Locations
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Australia
Nucleus Network Pty Ltd
Melbourne, Australia
Sponsors and Collaborators
H. Lundbeck A/S
Alder Biopharmaceuticals, Inc.
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
More Information
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT04197349    
Other Study ID Numbers: ALD1910-CLIN-001
18902A ( Other Identifier: H. Lundbeck A/S )
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sumatriptan
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
 Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs