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

Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04197349
• Other study ID #: ALD1910-CLIN-001
• Secondary ID: 18902A
• Status: Completed
• Phase: Phase 1
• Start date: September 24, 2019
• Est. completion date: August 19, 2020

Study information

• Verified date: September 2020
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: August 19, 2020
• Est. primary completion date: August 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine

Intervention

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

Locations

Country	Name	City	State
Australia	Nucleus Network Pty Ltd	Melbourne

Sponsors (2)

Lead Sponsor	Collaborator
H. Lundbeck A/S	Alder Biopharmaceuticals, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Area under the serum concentration-time curve (AUC(0-T))		From dosing to week 20
Secondary	Peak serum concentration (Cmax)		From dosing to week 20
Secondary	Clearance (Cl)		From dosing to week 20
Secondary	Immunogenicity	Number of anti-ALD1910 antibodies (ADA) and characterization of anti-ALD1910 ADA positive responses for neutralizing activity	From dosing to week 20