A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients (NCT03570957) | Clinical Trial Compass
CompletedPhase 1
A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients
Japan75 participantsStarted 2018-07-17
Plain-language summary
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.
Who can participate
Age range20 Years – 64 Years
SexALL
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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
What they're measuring
1
Safety and tolerability as measured by incidence of adverse events
Timeframe: Up to Day 113
2
Proportion of subjects who develop antibodies against MT-2990 in serum