Seasonal Allergic Rhinitis
Conditions
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.
Interventions
DRUGMT-2990
MT-2990 solution for injection in vial
DRUGPlacebo
Placebo solution for injection in vial
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| MT-2990 concentration in serum | Up to Day 113 | — |
| Maximum observed serum concentration (Cmax) 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) | Day 8, 29, 57, and 85 | 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. |
| Total ocular symptom score (TOSS) | Day 8, 29, 57, and 85 | 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. |
| Measured time of maximum observed serum concentration (tmax) of MT-2990 | Up to Day 113 | — |
| Change from baseline in TNSS | Day 8, 29, 57, and 85 | Baseline is pre-exposure. |
| 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 | — |
| Total symptom score (TSS) | Day 8, 29, 57, and 85 | TSS is TNSS plus TOSS. |
| Apparent terminal elimination half-life (t1/2) of MT-2990 | Up to Day 113 | — |
Countries
Japan
Outcome results
None listed