Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of QGE031 in Japanese Atopic Male Subjects
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01596712
First received: March 22, 2012
Last updated: November 20, 2012
Last verified: November 2012
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Purpose
This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of QGE031 in Japanese atopic male subjects in order to determine the eligibility of Japanese patients in subsequent clinical studies.
| Condition | Intervention | Phase |
|---|---|---|
|
Allergy |
Drug: QGE031 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Following Subcutaneous Injections of QGE031 in Japanese Atopic Male Subjects |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Number of Patients with Adverse Events [ Time Frame: Day 113 ] [ Designated as safety issue: Yes ]Adverse events will be determined by evaluating clinical, laboratory evaluations, impact on vital signs and impacts on ECGs and other safety assessments.
Secondary Outcome Measures:
- QGE031 serum concentration [ Time Frame: Pre-dose, 2, 4, 12, 24, 48, and 96 h post-dose, Days 8, 15, 22, 29, 43, 57, 71, 85, 99 and 113 ] [ Designated as safety issue: No ]Blood will be collected for the determination of serum QGE031 concentrations. Cmax, Tmax, Area Under the curve (AUC), terminal half-life of serum QGE031. These parameters will be determined using non-compartmental methods.
- Free and total IgE serum concentrations [ Time Frame: Pre-dose, 2, 4, 12, 24, 48, and 96 h post-dose, Days 8, 15, 22, 29, 43, 57, 71, 85, 99 and 113 ] [ Designated as safety issue: No ]Blood will be collected to measure serum IgE concentrations. Cmin, Tmin, and percent decrease of free IgE serum concentration will be determined. Cmax, Tmax, and percent increase of total IgE serum concentration will be determined.
- FcεRI expression and IgE binding on basophiles [ Time Frame: Pre-dose, 2, 24, 48, 96 h post-dose; Days 8, 15, 22, 29, 43, 57, 71, 85, 99, and 113 ] [ Designated as safety issue: No ]Blood will be collected to measure FcεRI expression and IgE binding on basophiles. Lots of individual values and mean values over time will be provided.
- Immunogenicity (Anti-QGE031 antibody in serum) [ Time Frame: Pre-dose, Days 29, 57 and 113 ] [ Designated as safety issue: Yes ]Blood will be collected to measure Immunogenicity. The number and percentage of subjects producing anti-QGE031 antibody will be presented.
| Enrollment: | 209 |
| Study Start Date: | March 2011 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: QGE031 Dose 1
QGE031 Dose 1: subcutaneous injection, single dose
|
Drug: QGE031
QGE031 was supplied as liquid in 2 mL vial for subcutaneous injection.
|
|
Experimental: QGE031 Dose 2
QGE031 Dose 2: subcutaneous injection, single dose
|
Drug: QGE031
QGE031 was supplied as liquid in 2 mL vial for subcutaneous injection.
|
|
Experimental: QGE031 Dose 3
QGE031 Dose 3: subcutaneous injection, single dose
|
Drug: QGE031
QGE031 was supplied as liquid in 2 mL vial for subcutaneous injection.
|
|
Placebo Comparator: Placebo
Placebo to QGE031 : subcutaneous injection, single dose
|
Drug: Placebo
Placebo was supplied as liquid in 2 mL vial for subcutaneous injection.
|
Eligibility| Ages Eligible for Study: | 20 Years to 55 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Male Japanese subjects who are atopic as determined by an in vitro test (CAP-RAST or MAST test)
- Serum IgE level must be equal to or greater than 30 IU/mL at screening.
Exclusion Criteria:
- Poorly controlled asthma i.e. symptoms of asthma (daytime or night-time) or use of short-acting beta agonist for relief of asthma (except with exercise) more than once a week
- Worsening of asthma signs and symptoms prompting a medical intervention within 1 year prior to dosing
- Severe atopic dermatitis within 1 year prior to dosing, defined by a history of eruption with severe inflammation such as erythema, papule, erosion, infiltration and lichen
- Severe allergic rhinitis strongly disturbing daily life within 1 year prior to dosing
- Severe allergic conjunctivitis (e.g., episodes of giant papillary, limbal proliferation, shield ulcer) within 1 year prior to dosing
- Prior use of Xolair® or other anti-IgE antibodies
- Concomitant use of allergy vaccination therapy
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01596712 History of Changes |
| Other Study ID Numbers: | CQGE031A1101 |
| Study First Received: | March 22, 2012 |
| Last Updated: | November 20, 2012 |
| Health Authority: | United States: Food and Drug Administration Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Novartis:
|
Allergy, Asthma, Atopic dermatitis, |
Japanese, QGE031, IgE |
Additional relevant MeSH terms:
|
Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013