A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients
NCT ID: NCT03570957
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
75 participants
INTERVENTIONAL
2018-07-17
2018-12-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MT-2990, Low dose
Single intravenous dose
MT-2990
MT-2990 solution for injection in vial
Placebo
Placebo solution for injection in vial
MT-2990, Low-middle dose
Single intravenous dose
MT-2990
MT-2990 solution for injection in vial
Placebo
Placebo solution for injection in vial
MT-2990, High-middle dose
Single intravenous dose
MT-2990
MT-2990 solution for injection in vial
Placebo
Placebo solution for injection in vial
MT-2990, High dose
Single intravenous dose
MT-2990
MT-2990 solution for injection in vial
Placebo
Single intravenous dose
Placebo
Placebo solution for injection in vial
Interventions
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MT-2990
MT-2990 solution for injection in vial
Placebo
Placebo solution for injection in vial
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
64 Years
ALL
No
Sponsors
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Tanabe Pharma Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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General Manager
Role: STUDY_DIRECTOR
Tanabe Pharma Corporation
Locations
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Investigational Site
Tokyo, , Japan
Countries
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Other Identifiers
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MT-2990-J01
Identifier Type: -
Identifier Source: org_study_id
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