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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

Tracking Information
First Submitted Date  ICMJE December 11, 2019
First Posted Date  ICMJE December 13, 2019
Last Update Posted Date September 23, 2020
Actual Study Start Date  ICMJE September 24, 2019
Actual Primary Completion Date August 19, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2019)
  • 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 ]
    Number of anti-ALD1910 antibodies (ADA) and characterization of anti-ALD1910 ADA positive responses for neutralizing activity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE
  • Biological: ALD1910
    Single Dose IV infusion
  • Biological: Sumatriptan
    Single dose subcutaneous injection
  • Biological: ALD1910
    Single dose subcutaneous injection
Study Arms  ICMJE
  • Experimental: Part A Cohort 1-8
    ALD1910/Placebo; Single Dose IV infusion on Day 1
    Intervention: Biological: ALD1910
  • Experimental: Part B Cohort 9
    ALD1910/Placebo+Sumatriptan; Single Dose IV infusion on Day 1
    Interventions:
    • Biological: ALD1910
    • Biological: Sumatriptan
  • Experimental: Part B Cohort 10
    ALD1910/Placebo; Single dose subcutaneous injection on Day 1
    Intervention: Biological: ALD1910
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2019)
96
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 19, 2020
Actual Primary Completion Date August 19, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04197349
Other Study ID Numbers  ICMJE ALD1910-CLIN-001
18902A ( Other Identifier: H. Lundbeck A/S )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lundbeck A/S
Study Sponsor  ICMJE H. Lundbeck A/S
Collaborators  ICMJE Alder Biopharmaceuticals, Inc.
Investigators  ICMJE
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
PRS Account H. Lundbeck A/S
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP