Safety Tolerability and Pharmacokinetics of ALD403

Phase 1

Completed

• Conditions: Migraine Disorders
• Interventions: Biological: ALD403; Biological: Sumatriptan

• Registration Number: NCT01579383
• Lead Sponsor: Alder Biopharmaceuticals, Inc.

Brief Summary

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of ALD403, a monoclonal antibody, administered by intravenous infusion and subcutaneous injection.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-16
• Study First Submitted QC: 2012-04-16
• Study First Posted: 2012-04-18
• Primary Completion: 2012-12
• Status Verified: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2013-04-25
• Last Update Posted: 2013-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Part A, Cohorts A - H	ALD403	ALD403/Placebo
Part A, Cohort I	ALD403	ALD403/Placebo
Part B	ALD403	ALD403/Placebo/Sumatriptan
Part B	Sumatriptan	ALD403/Placebo/Sumatriptan

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of ALD403: laboratory variables, ECG and adverse events	12 weeks	* Physical Examination; * Vital signs; * 12-lead ECG (electrocardiogram); * Clinical laboratory tests (hematology, chemistry); * Number of participants with Adverse Events

Secondary Outcome Measures

Name	Time	Method
Evaluation of Pharmacokinetics of ALD403	12 weeks	* Cmax - maximum plasma concentration; * Tmax - Time to achieve maximum plasma concentration; * AUC - Area under the plasma concentration-time curve; * T1/2 - Elimination half-life; * Vz - Volume of distribution; * CL - Clearance; * Bioavailability
Evaluation of pharmacodynamics of ALD403	12 weeks	* Blood perfusion rates; * Plasma levels of unbound ALD403; * Immunogenicity

Trial Locations

Locations (1)

Centre for Clinical Studies, Nucleus Network; 🇦🇺 Melbourne, Victoria, Australia