Clinical trial NCT03570957: A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients
Official title: A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients (Single Dose Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2018-06-27
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability as measured by incidence of adverse events
timeFrame: Up to Day 113
measure: Proportion of subjects who develop antibodies against MT-2990 in serum
timeFrame: Up to Day 113
Secondary outcomes:
measure: MT-2990 concentration in serum
timeFrame: Up to Day 113
measure: Maximum observed serum concentration (Cmax) of MT-2990
timeFrame: Up to Day 113
measure: Measured time of maximum observed serum concentration (tmax) of MT-2990
timeFrame: Up to Day 113
measure: Apparent terminal elimination half-life (t1/2) of MT-2990
timeFrame: Up to Day 113
measure: AUC from time zero to the last measurable concentration (AUC0-last) of MT-2990
timeFrame: Up to Day 113
measure: AUC from time zero to infinity (AUC0-∞) of MT-2990
timeFrame: Up to Day 113
measure: Terminal elimination rate constant (kel) of MT-2990
timeFrame: Up to Day 113
measure: Apparent volume of distribution at steady state (Vss) of MT-2990
timeFrame: Up to Day 113
measure: Apparent volume of distribution during terminal phase after IV administration (Vz) of MT-2990
timeFrame: Up to Day 113
measure: Mean residence time from time zero to infinity (MRT0-∞) of MT-2990
timeFrame: Up to Day 113
measure: Apparent serum clearance (CL) of MT-2990
timeFrame: Up to Day 113
measure: Percentage of AUC obtained by extrapolation (%AUCex) of MT-2990
timeFrame: Up to Day 113
measure: Total nasal symptom score (TNSS)
timeFrame: Day 8, 29, 57, and 85
measure: Total ocular symptom score (TOSS)
timeFrame: Day 8, 29, 57, and 85
measure: Total symptom score (TSS)
timeFrame: Day 8, 29, 57, and 85
measure: Change from baseline in TNSS
timeFrame: Day 8, 29, 57, and 85
measure: Change from baseline in TOSS
timeFrame: Day 8, 29, 57, and 85
measure: Change from baseline in TSS
timeFrame: Day 8, 29, 57, and 85
measure: Sum of TNSS during allergen exposure in EEC
timeFrame: Day 8, 29, 57, and 85
measure: Sum of TOSS during allergen exposure in EEC
timeFrame: Day 8, 29, 57, and 85
measure: Sum of TSS during allergen exposure in EEC
timeFrame: Day 8, 29, 57, and 85
measure: AUC of TNSS after allergen exposure
timeFrame: Day 8, 29, 57, and 85
measure: AUC of TOSS after allergen exposure
timeFrame: Day 8, 29, 57, and 85
measure: AUC of TSS after allergen exposure
timeFrame: Day 8, 29, 57, and 85
measure: Proportion of subjects with increased TNSS from baseline
timeFrame: Day 8, 29, 57, and 85
measure: Proportion of subjects with increased TOSS from baseline
timeFrame: Day 8, 29, 57, and 85
measure: Proportion of subjects with increased TSS from baseline
timeFrame: Day 8, 29, 57, and 85
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Investigational Site
Study officials:
affiliation: Mitsubishi Tanabe Pharma Corporation
name: General Manager
role: STUDY_DIRECTOR
References: