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

September 21, 2020 updated by: H. Lundbeck A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

96

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia
        • Nucleus Network Pty Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A Cohort 1-8
ALD1910/Placebo; Single Dose IV infusion on Day 1
Biological: ALD1910
Single Dose IV infusion
Biological: ALD1910
Single dose subcutaneous injection
Experimental: Part B Cohort 9
ALD1910/Placebo+Sumatriptan; Single Dose IV infusion on Day 1
Biological: ALD1910
Single Dose IV infusion
Biological: ALD1910
Single dose subcutaneous injection
Biological: Sumatriptan
Single dose subcutaneous injection
Experimental: Part B Cohort 10
ALD1910/Placebo; Single dose subcutaneous injection on Day 1
Biological: ALD1910
Single Dose IV infusion
Biological: ALD1910
Single dose subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From dosing to week 20

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the serum concentration-time curve (AUC(0-T))
Time Frame: From dosing to week 20
From dosing to week 20
Peak serum concentration (Cmax)
Time Frame: From dosing to week 20
From dosing to week 20
Clearance (Cl)
Time Frame: From dosing to week 20
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
From dosing to week 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Collaborators

Alder Biopharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2019

Primary Completion (Actual)

August 19, 2020

Study Completion (Actual)

August 19, 2020

Study Registration Dates

First Submitted

December 11, 2019

First Submitted That Met QC Criteria

December 11, 2019

First Posted (Actual)

December 13, 2019

Study Record Updates

Last Update Posted (Actual)

September 23, 2020

Last Update Submitted That Met QC Criteria

September 21, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALD1910-CLIN-001
  • 18902A (Other Identifier: H. Lundbeck A/S)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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