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

Study Overview
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Brief Summary
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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.

Official Title
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A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients (Single Dose Study)

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: MT-2990
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT-2990, Low dose<br>Single intravenous dose | Drug: MT-2990<br>* MT-2990 solution for injection in vial<br>Drug: Placebo<br>* Placebo solution for injection in vial<br>|
| Experimental: MT-2990, Low-middle dose<br>Single intravenous dose | Drug: MT-2990<br>* MT-2990 solution for injection in vial<br>Drug: Placebo<br>* Placebo solution for injection in vial<br>|
| Experimental: MT-2990, High-middle dose<br>Single intravenous dose | Drug: MT-2990<br>* MT-2990 solution for injection in vial<br>Drug: Placebo<br>* Placebo solution for injection in vial<br>|
| Experimental: MT-2990, High dose<br>Single intravenous dose | Drug: MT-2990<br>* MT-2990 solution for injection in vial<br>|
| Placebo Comparator: Placebo<br>Single intravenous dose | Drug: Placebo<br>* Placebo solution for injection in vial<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as measured by incidence of adverse events |  | Up to Day 113 | 
| Proportion of subjects who develop antibodies against MT-2990 in serum |  | Up to Day 113 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MT-2990 concentration in serum |  | Up to Day 113 | 
| Maximum observed serum concentration (Cmax) of MT-2990 |  | Up to Day 113 | 
| Measured time of maximum observed serum concentration (tmax) of MT-2990 |  | Up to Day 113 | 
| Apparent terminal elimination half-life (t1/2) of MT-2990 |  | Up to Day 113 | 
| AUC from time zero to the last measurable concentration (AUC0-last) of MT-2990 |  | Up to Day 113 | 
| AUC from time zero to infinity (AUC0-∞) of MT-2990 |  | Up to Day 113 | 
| Terminal elimination rate constant (kel) of MT-2990 |  | Up to Day 113 | 
| Apparent volume of distribution at steady state (Vss) of MT-2990 |  | Up to Day 113 | 
| Apparent volume of distribution during terminal phase after IV administration (Vz) of MT-2990 |  | Up to Day 113 | 
| Mean residence time from time zero to infinity (MRT0-∞) of MT-2990 |  | Up to Day 113 | 
| Apparent serum clearance (CL) of MT-2990 |  | Up to Day 113 | 
| Percentage of AUC obtained by extrapolation (%AUCex) of MT-2990 |  | Up to Day 113 | 
| Total nasal symptom score (TNSS) | Four nasal symptoms (runny nose, sneezing, blocked nose, and itchy nose) are recorded using a 5-point scale of 0 (none) to 4 (very severe). TNSS is sum of 4 nasal symptoms, score range is 0 to 16. | Day 8, 29, 57, and 85 | 
| Total ocular symptom score (TOSS) | Two ocular symptoms (itchy eyes and watery eyes) are recorded using a 5-point scale of 0 (none) to 4 (very severe). TOSS is sum of 2 ocular symptoms, score range is 0 to 8. | Day 8, 29, 57, and 85 | 
| Total symptom score (TSS) | TSS is TNSS plus TOSS. | Day 8, 29, 57, and 85 | 
| Change from baseline in TNSS | Baseline is pre-exposure. | Day 8, 29, 57, and 85 | 
| Change from baseline in TOSS |  | Day 8, 29, 57, and 85 | 
| Change from baseline in TSS |  | Day 8, 29, 57, and 85 | 
| Sum of TNSS during allergen exposure in EEC |  | Day 8, 29, 57, and 85 | 
| Sum of TOSS during allergen exposure in EEC |  | Day 8, 29, 57, and 85 | 
| Sum of TSS during allergen exposure in EEC |  | Day 8, 29, 57, and 85 | 
| AUC of TNSS after allergen exposure |  | Day 8, 29, 57, and 85 | 
| AUC of TOSS after allergen exposure |  | Day 8, 29, 57, and 85 | 
| AUC of TSS after allergen exposure |  | Day 8, 29, 57, and 85 | 
| Proportion of subjects with increased TNSS from baseline |  | Day 8, 29, 57, and 85 | 
| Proportion of subjects with increased TOSS from baseline |  | Day 8, 29, 57, and 85 | 
| Proportion of subjects with increased TSS from baseline |  | Day 8, 29, 57, and 85 |