Safety and Tolerability of Single and Multiple Doses of VAK694 in Healthy and Atopic Subjects

A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetic Profile and Pharmacodynamic Effect of Single and Multiple Doses of VAK694 in Healthy and Atopic Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00620230

Enrollment

Registered

2008-02-21

Start date

2007-10-31

Completion date

2008-04-30

Last updated

2010-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Keywords

Allergic rhinitis, anti-interleukin 4

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.

Interventions

DRUGNVP-VAK694

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* History of allergic rhinitis (Part 2 only)

Exclusion criteria

* Very low or high body weight * Heavy or recent smoker * Exposure to human monoclonal antibodies Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Routine safety observations and pharmacokinetic measurements	throughout the study

Secondary

Measure	Time frame
Routine safety observations and pharmacokinetic measurements	throughout the study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026