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

NCT04197349 | Completed Phase 1

• 2 other identifiers: ALD1910-CLIN-00118902A
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-emergent adverse events

  Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, ECG parameters)

  From dosing to week 20

Secondary Outcomes (4)

• Area under the serum concentration-time curve (AUC(0-T))

  From dosing to week 20

• Peak serum concentration (Cmax)

  From dosing to week 20

• Clearance (Cl)

  From dosing to week 20

• Immunogenicity

  From dosing to week 20

Study Arms (3)

Part A Cohort 1-8

EXPERIMENTAL

ALD1910/Placebo; Single Dose IV infusion on Day 1

Biological: ALD1910

Part B Cohort 9

EXPERIMENTAL

ALD1910/Placebo+Sumatriptan; Single Dose IV infusion on Day 1

Biological: ALD1910; Biological: Sumatriptan

Part B Cohort 10

EXPERIMENTAL

ALD1910/Placebo; Single dose subcutaneous injection on Day 1

Biological: ALD1910

Interventions

ALD1910 BIOLOGICAL

Single Dose IV infusion

Part A Cohort 1-8; Part B Cohort 9

Sumatriptan BIOLOGICAL

Single dose subcutaneous injection

Part B Cohort 9

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lundbeck A/S: lead
• Alder Biopharmaceuticals, Inc.: collaborator

Study Sites (1)

Nucleus Network Pty Ltd

Melbourne, Australia

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Sumatriptan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 13, 2019
• Study Start: September 24, 2019
• Primary Completion: August 19, 2020
• Study Completion: August 19, 2020
• Last Updated: September 23, 2020

Record last verified: 2020-09

Locations

AU (1)