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

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Migraine

Treatments: Biological: Sumatriptan; Biological: ALD1910

Study type: Interventional

Funder types: Industry

Identifiers

NCT04197349

ALD1910-CLIN-001

18902A (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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96 participants in 3 patient groups

Part A Cohort 1-8

Experimental group

Description:

ALD1910/Placebo; Single Dose IV infusion on Day 1

Treatment:

Biological: ALD1910

Biological: ALD1910

Part B Cohort 9

Experimental group

Description:

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

Treatment:

Biological: ALD1910

Biological: ALD1910

Biological: Sumatriptan

Part B Cohort 10

Experimental group

Description:

ALD1910/Placebo; Single dose subcutaneous injection on Day 1

Treatment:

Biological: ALD1910

Biological: ALD1910