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

NCT ID: NCT03570957

Last Updated: 2025-12-11

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-17

Study Completion Date

2018-12-27

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.

Detailed Description

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Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MT-2990, Low dose

Single intravenous dose

Group Type EXPERIMENTAL

MT-2990

Intervention Type DRUG

MT-2990 solution for injection in vial

Placebo

Intervention Type DRUG

Placebo solution for injection in vial

MT-2990, Low-middle dose

Single intravenous dose

Group Type EXPERIMENTAL

MT-2990

Intervention Type DRUG

MT-2990 solution for injection in vial

Placebo

Intervention Type DRUG

Placebo solution for injection in vial

MT-2990, High-middle dose

Single intravenous dose

Group Type EXPERIMENTAL

MT-2990

Intervention Type DRUG

MT-2990 solution for injection in vial

Placebo

Intervention Type DRUG

Placebo solution for injection in vial

MT-2990, High dose

Single intravenous dose

Group Type EXPERIMENTAL

MT-2990

Intervention Type DRUG

MT-2990 solution for injection in vial

Placebo

Single intravenous dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo solution for injection in vial

Interventions

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MT-2990

MT-2990 solution for injection in vial

Intervention Type DRUG

Placebo

Placebo solution for injection in vial

Intervention Type DRUG

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanabe Pharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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General Manager

Role: STUDY_DIRECTOR

Tanabe Pharma Corporation

Locations

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Investigational Site

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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MT-2990-J01

Identifier Type: -

Identifier Source: org_study_id

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