NCT01579383

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 26, 2013

Status Verified

April 1, 2013

Enrollment Period

8 months

First QC Date

April 16, 2012

Last Update Submit

April 25, 2013

Conditions

Migraine Disorders

Keywords

Migraine DisordersPhase 1ALD403

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of ALD403: laboratory variables, ECG and adverse events

    * Physical Examination * Vital signs * 12-lead ECG (electrocardiogram) * Clinical laboratory tests (hematology, chemistry) * Number of participants with Adverse Events

    12 weeks

Secondary Outcomes (2)

  • Evaluation of Pharmacokinetics of ALD403

    12 weeks

  • Evaluation of pharmacodynamics of ALD403

    12 weeks

Study Arms (3)

Part A, Cohorts A - H

EXPERIMENTAL

ALD403/Placebo

Biological: ALD403

Part A, Cohort I

EXPERIMENTAL

ALD403/Placebo

Biological: ALD403

Part B

EXPERIMENTAL

ALD403/Placebo/Sumatriptan

Biological: ALD403Biological: Sumatriptan

Interventions

ALD403BIOLOGICAL

Single Dose IV infusion on Day 1

Part A, Cohorts A - HPart B
SumatriptanBIOLOGICAL

Single Dose subcutaneous injection on Day 1

Part B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy males and females between the ages of 18 and 65 (inclusive).
  • Normal renal function as calculated by the Cockcroft- Gault equation at screening.
  • Body Mass Index (BMI) between 18.0 and 30.0 kg/m2, and a total body weight of 50 to 100kg inclusive.
  • No clinically significant disease or abnormal laboratory values as determined by medical history, physical examination, electrocardiogram, and laboratory evaluations

You may not qualify if:

  • History of febrile illness within 5 days prior to the first dose
  • Any clinically significant laboratory findings
  • Any clinically significant physical exam abnormalities
  • Hospitalization for any reason within 30 days of the screening visit.
  • History of or positive human immunodeficiency virus (HIV) screen result
  • History of positive Hepatitis B surface antigen (HBsAg), and/or positive Hepatitis C antibody (HCV) at screening.
  • History of malignancy within five years prior to screening.
  • History of leukemia, myeloproliferative disorder or lymphoproliferative disorder
  • History of rubber, latex allergy or allergy to medical adhesives
  • Positive urine, drug or alcohol screen result
  • Current smokers
  • Previous treatment or clinical trial with a monoclonal antibody.
  • Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives
  • Healthy females between the ages of 18 and 65 (inclusive).
  • Male and female migraine patients with clinically diagnosed migraine not attributed to another cause with or without aura based on International Headache Society criteria.
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Clinical Studies, Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

eptinezumabSumatriptan

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsTryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Peter Hodsman, MD

    Nucleus Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2012

First Posted

April 18, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2012

Study Completion

April 1, 2013

Last Updated

April 26, 2013

Record last verified: 2013-04

Locations

AU(1)