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

• ClinicalTrials.gov Identifier: NCT04197349
• Recruitment Status: Completed
• First Posted: December 13, 2019
• Last Update Posted: September 23, 2020
• Sponsor: H. Lundbeck A/S
• Collaborator: Alder Biopharmaceuticals, Inc.
• Information provided by (Responsible Party): H. Lundbeck A/S

Tracking Information

• First Submitted Date: December 11, 2019
• First Posted Date: December 13, 2019
• Last Update Posted Date: September 23, 2020
• Actual Study Start Date: September 24, 2019
• Actual Primary Completion Date: August 19, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman
• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Migraine

Intervention

• Biological: ALD1910
  Single Dose IV infusion
• Biological: Sumatriptan
  Single dose subcutaneous injection
• Biological: ALD1910
  Single dose subcutaneous injection

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 11, 2019): 96
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 19, 2020
• Actual Primary Completion Date: August 19, 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia

Administrative Information

• NCT Number: NCT04197349
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: H. Lundbeck A/S
• Original Responsible Party: Same as current
• Current Study Sponsor: H. Lundbeck A/S
• Original Study Sponsor: Same as current
• Collaborators: Alder Biopharmaceuticals, Inc.

Investigators

• Study Director: Email contact via H. Lundbeck A/S; LundbeckClinicalTrials@lundbeck.com

• PRS Account: H. Lundbeck A/S
• Verification Date: September 2020