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Completed

NCT Number: NCT04197349

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

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network Pty Ltd

Melbourne, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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

Treatment and study plan

ALD1910

Biological

Single Dose IV infusion

Sumatriptan

Biological

Single dose subcutaneous injection

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Collaborators

  • Alder Biopharmaceuticals, Inc.

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 13, 2019
Registry last updated
Sep 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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