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

Phase 1CompletedNCT04197349

H. Lundbeck A/S96 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Migraine

Interventions

ALD1910BIOLOGICAL

Single Dose IV infusion

SumatriptanBIOLOGICAL

Single dose subcutaneous injection

ALD1910BIOLOGICAL

Single dose subcutaneous injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Nucleus Network Pty Ltd

Melbourne, Australia

Outcomes

Primary Outcomes

Number of participants with treatment-emergent adverse events

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