NCT00620230

Brief Summary

This study will evaluate the safety and tolerability of single and multiple doses of VAK694 in healthy volunteers and otherwise healthy volunteers with a history of allergies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 21, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

September 27, 2010

Status Verified

September 1, 2010

Enrollment Period

6 months

First QC Date

February 7, 2008

Last Update Submit

September 24, 2010

Conditions

Allergic Rhinitis

Keywords

Allergic rhinitis, anti-interleukin 4

Outcome Measures

Primary Outcomes (1)

  • Routine safety observations and pharmacokinetic measurements

    throughout the study

Secondary Outcomes (1)

  • Routine safety observations and pharmacokinetic measurements

    throughout the study

Study Arms (2)

1

EXPERIMENTAL
Drug: NVP-VAK694

2

PLACEBO COMPARATOR
Drug: NVP-VAK694

Interventions

NVP-VAK694DRUG
1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • History of allergic rhinitis (Part 2 only)

You may not qualify if:

  • Very low or high body weight
  • Heavy or recent smoker
  • Exposure to human monoclonal antibodies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigator Site

North Miami Beach, Florida, 33169, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Novartis

    Novartis investigator site

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 7, 2008

First Posted

February 21, 2008

Study Start

October 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

September 27, 2010

Record last verified: 2010-09

Locations

US(1)