Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT-2990, Low dose | Experimental | Single intravenous dose |
|
| MT-2990, Low-middle dose | Experimental | Single intravenous dose |
|
| MT-2990, High-middle dose | Experimental | Single intravenous dose |
|
| MT-2990, High dose | Experimental | Single intravenous dose |
|
| Placebo | Placebo Comparator | Single intravenous dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-2990 | Drug | MT-2990 solution for injection in vial |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| MT-2990 concentration in serum | Up to Day 113 | |
| Maximum observed serum concentration (Cmax) of MT-2990 | Up to Day 113 | |
| Measured time of maximum observed serum concentration (tmax) of MT-2990 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| General Manager | Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Tokyo | Japan |
Not provided
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo solution for injection in vial |
|
| Up to Day 113 |
| Apparent terminal elimination half-life (t1/2) 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) | 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. | Day 8, 29, 57, and 85 |
| Total ocular symptom score (TOSS) | 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. | Day 8, 29, 57, and 85 |
| Total symptom score (TSS) | TSS is TNSS plus TOSS. | Day 8, 29, 57, and 85 |
| Change from baseline in TNSS | Baseline is pre-exposure. | Day 8, 29, 57, and 85 |
| 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 |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |