A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients

Tanabe Pharma Corporation75 enrolled

Overview

The objective of this study is to investigate the safety, tolerability, and pharmacokinetics of MT-2990 in patients with Japanese cedar pollen-induced seasonal allergic rhinitis (JC-SAR). Additional objective of the study is to investigate the efficacy and pharmacodynamics profile of MT-2990 in an environmental exposure chamber (EEC) on Day 8, 29, 57, and 85.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Seasonal Allergic Rhinitis

Interventions

MT-2990DRUG

MT-2990 solution for injection in vial

PlaceboDRUG

Placebo solution for injection in vial

Eligibility

Sex: ALLMin age: 20 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A body weight of 40 to 100 kg for female or 45 to 100 kg for male * A body mass index of 18 to 30 kg/m2 * Subjects who have current history of JC-SAR in previous 2 consecutive years. * Presence (CAP-RAST: ≥2) of IgE specific to Japanese cedar pollens and absence (CAP-RAST: ≤1) of IgE specific to other 4 allergens * Presence of at least 2 symptoms, which are moderate to very severe, in 4 nasal symptoms (runny nose, sneezing, blocked nose, itchy nose) at any time point during allergen exposure in EEC at screening period Exclusion Criteria: * Presence of any symptoms of allergic rhinitis within 1 year except scattering season of cedar pollen or cypress pollen * Subjects who have persistent symptom caused by allergen exposure in EEC at screening period until Day 1 (pre-dose) * Underwent nasal surgery (include laser surgery) to improve nasal symptoms within 2 years * Underwent specific immunotherapy or non-specific immunotherapy within 5 years * Underwent medication of anti-histamine, oral mast cell stabilizer, leukotriene receptor antagonist, prostaglandin D2/thromboxane A2 receptor antagonist, Th2 cytokine inhibitor, corticosteroid (oral form, intra-nasal form, ocular form), or vasoconstrictor within 4 weeks * Underwent medication of corticosteroid (injection form) or anti-IgE antibody within 6 months * Subject who is concerned about exacerbation of the physical condition due to allergen exposure in EEC

Locations (1)

Investigational Site

Tokyo, Japan

Outcomes

Primary Outcomes

Safety and tolerability as measured by incidence of adverse events

Time frame: Up to Day 113

Proportion of subjects who develop antibodies against MT-2990 in serum

Time frame: Up to Day 113

Secondary Outcomes

MT-2990 concentration in serum

Time frame: Up to Day 113

Maximum observed serum concentration (Cmax) of MT-2990

Time frame: Up to Day 113

Measured time of maximum observed serum concentration (tmax) of MT-2990

Time frame: Up to Day 113

Apparent terminal elimination half-life (t1/2) of MT-2990

Time frame: Up to Day 113

AUC from time zero to the last measurable concentration (AUC0-last) of MT-2990

Time frame: Up to Day 113

AUC from time zero to infinity (AUC0-∞) of MT-2990

Time frame: Up to Day 113

Terminal elimination rate constant (kel) of MT-2990

Time frame: Up to Day 113

Apparent volume of distribution at steady state (Vss) of MT-2990

Time frame: Up to Day 113

Apparent volume of distribution during terminal phase after IV administration (Vz) of MT-2990

Time frame: Up to Day 113

Data from ClinicalTrials.gov

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