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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-24

Study Completion Date

2020-08-19

Brief Summary

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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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Detailed Description

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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.

Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part A Cohort 1-8

ALD1910/Placebo; Single Dose IV infusion on Day 1

Group Type EXPERIMENTAL

ALD1910

Intervention Type BIOLOGICAL

Single Dose IV infusion

Part B Cohort 9

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

Group Type EXPERIMENTAL

ALD1910

Intervention Type BIOLOGICAL

Single Dose IV infusion

Sumatriptan

Intervention Type BIOLOGICAL

Single dose subcutaneous injection

Part B Cohort 10

ALD1910/Placebo; Single dose subcutaneous injection on Day 1

Group Type EXPERIMENTAL

ALD1910

Intervention Type BIOLOGICAL

Single dose subcutaneous injection

Interventions

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ALD1910

Single Dose IV infusion

Intervention Type BIOLOGICAL

Sumatriptan

Single dose subcutaneous injection

Intervention Type BIOLOGICAL

ALD1910

Single dose subcutaneous injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes