Seasonal Allergic RhinitisPhase 1NCT03570957
A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients
A Phase 1 study testing MT-2990 in people with Seasonal Allergic Rhinitis, run by Tanabe Pharma Corporation at 1 site in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- MT-2990
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteJapan
- Study dates
- 17 Jul 2018to 27 Dec 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients (Single Dose Study)
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.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- MT-2990, Placebo
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-2990Drug
MT-2990 solution for injection in vial
PlaceboDrug
Placebo solution for injection in vial
| Study group | Role | What they receive |
|---|---|---|
| MT-2990, Low dose | Experimental | Single intravenous dose Receives: Drug: MT-2990; Drug: Placebo |
| MT-2990, Low-middle dose | Experimental | Single intravenous dose Receives: Drug: MT-2990; Drug: Placebo |
| MT-2990, High-middle dose | Experimental | Single intravenous dose Receives: Drug: MT-2990; Drug: Placebo |
| MT-2990, High dose | Experimental | Single intravenous dose Receives: Drug: MT-2990 |
| Placebo | Placebo comparator | Single intravenous dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as measured by incidence of adverse events
Measured: Up to Day 113
Proportion of subjects who develop antibodies against MT-2990 in serum
Measured: Up to Day 113
Secondary outcomes (27)
MT-2990 concentration in serum
Measured: Up to Day 113
Maximum observed serum concentration (Cmax) of MT-2990
Measured: Up to Day 113
Measured time of maximum observed serum concentration (tmax) of MT-2990
Measured: Up to Day 113
Apparent terminal elimination half-life (t1/2) of MT-2990
Measured: Up to Day 113
AUC from time zero to the last measurable concentration (AUC0-last) of MT-2990
Measured: Up to Day 113
AUC from time zero to infinity (AUC0-∞) of MT-2990
Measured: Up to Day 113
Terminal elimination rate constant (kel) of MT-2990
Measured: Up to Day 113
Apparent volume of distribution at steady state (Vss) of MT-2990
Measured: Up to Day 113
Apparent volume of distribution during terminal phase after IV administration (Vz) of MT-2990
Measured: Up to Day 113
Mean residence time from time zero to infinity (MRT0-∞) of MT-2990
Measured: Up to Day 113
Apparent serum clearance (CL) of MT-2990
Measured: Up to Day 113
Percentage of AUC obtained by extrapolation (%AUCex) of MT-2990
Measured: 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.
Measured: 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.
Measured: Day 8, 29, 57, and 85
Total symptom score (TSS)
TSS is TNSS plus TOSS.
Measured: Day 8, 29, 57, and 85
Change from baseline in TNSS
Baseline is pre-exposure.
Measured: Day 8, 29, 57, and 85
Change from baseline in TOSS
Measured: Day 8, 29, 57, and 85
Change from baseline in TSS
Measured: Day 8, 29, 57, and 85
Sum of TNSS during allergen exposure in EEC
Measured: Day 8, 29, 57, and 85
Sum of TOSS during allergen exposure in EEC
Measured: Day 8, 29, 57, and 85
Sum of TSS during allergen exposure in EEC
Measured: Day 8, 29, 57, and 85
AUC of TNSS after allergen exposure
Measured: Day 8, 29, 57, and 85
AUC of TOSS after allergen exposure
Measured: Day 8, 29, 57, and 85
AUC of TSS after allergen exposure
Measured: Day 8, 29, 57, and 85
Proportion of subjects with increased TNSS from baseline
Measured: Day 8, 29, 57, and 85
Proportion of subjects with increased TOSS from baseline
Measured: Day 8, 29, 57, and 85
Proportion of subjects with increased TSS from baseline
Measured: Day 8, 29, 57, and 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start17 Jul 2018
- Primary completion27 Dec 2018
- Study completion27 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- General Manager, Study director, Tanabe Pharma Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570957
- Sponsor's protocol ID
- MT-2990-J01
- Status last verified
- Dec 2025
- First submitted
- 18 Jun 2018
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients (Single Dose Study)
- ClinicalTrials.gov ID
- NCT03570957
- Acronym / sponsor ID
- MT-2990-J01
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 27 Dec 2018 (actual)
- Study completion
- 27 Dec 2018 (actual)
- First posted
- 27 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MT-2990, Low dose | Experimental | Drug: MT-2990, Drug: PlaceboSingle intravenous dose |
| MT-2990, Low-middle dose | Experimental | Drug: MT-2990, Drug: PlaceboSingle intravenous dose |
| MT-2990, High-middle dose | Experimental | Drug: MT-2990, Drug: PlaceboSingle intravenous dose |
| MT-2990, High dose | Experimental | Drug: MT-2990Single intravenous dose |
| Placebo | Placebo comparator | Drug: PlaceboSingle intravenous dose |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT-2990MT-2990 solution for injection in vial | Drug | MT-2990, High dose, MT-2990, High-middle dose, MT-2990, Low dose, MT-2990, Low-middle dose |
| PlaceboPlacebo solution for injection in vial | Drug | MT-2990, High-middle dose, MT-2990, Low dose, MT-2990, Low-middle dose, Placebo |
Primary outcome
Safety and tolerability as measured by incidence of adverse events
Time frame: Up to Day 113
Proportion of subjects who develop antibodies against MT-2990 in serum
Time frame: Up to Day 113
27 secondary outcomes
MT-2990 concentration in serum
Time frame: Up to Day 113
Maximum observed serum concentration (Cmax) of MT-2990
Time frame: Up to Day 113
Measured time of maximum observed serum concentration (tmax) of MT-2990
Time frame: Up to Day 113
Apparent terminal elimination half-life (t1/2) of MT-2990
Time frame: Up to Day 113
AUC from time zero to the last measurable concentration (AUC0-last) of MT-2990
Time frame: Up to Day 113
AUC from time zero to infinity (AUC0-∞) of MT-2990
Time frame: Up to Day 113
Terminal elimination rate constant (kel) of MT-2990
Time frame: Up to Day 113
Apparent volume of distribution at steady state (Vss) of MT-2990
Time frame: Up to Day 113
Apparent volume of distribution during terminal phase after IV administration (Vz) of MT-2990
Time frame: Up to Day 113
Mean residence time from time zero to infinity (MRT0-∞) of MT-2990
Time frame: Up to Day 113
Apparent serum clearance (CL) of MT-2990
Time frame: Up to Day 113
Percentage of AUC obtained by extrapolation (%AUCex) of MT-2990
Time frame: Up to Day 113
Total nasal symptom score (TNSS)
Time frame: Day 8, 29, 57, and 85
Total ocular symptom score (TOSS)
Time frame: Day 8, 29, 57, and 85
Total symptom score (TSS)
Time frame: Day 8, 29, 57, and 85
Change from baseline in TNSS
Time frame: Day 8, 29, 57, and 85
Change from baseline in TOSS
Time frame: Day 8, 29, 57, and 85
Change from baseline in TSS
Time frame: Day 8, 29, 57, and 85
Sum of TNSS during allergen exposure in EEC
Time frame: Day 8, 29, 57, and 85
Sum of TOSS during allergen exposure in EEC
Time frame: Day 8, 29, 57, and 85
Sum of TSS during allergen exposure in EEC
Time frame: Day 8, 29, 57, and 85
AUC of TNSS after allergen exposure
Time frame: Day 8, 29, 57, and 85
AUC of TOSS after allergen exposure
Time frame: Day 8, 29, 57, and 85
AUC of TSS after allergen exposure
Time frame: Day 8, 29, 57, and 85
Proportion of subjects with increased TNSS from baseline
Time frame: Day 8, 29, 57, and 85
Proportion of subjects with increased TOSS from baseline
Time frame: Day 8, 29, 57, and 85
Proportion of subjects with increased TSS from baseline
Time frame: Day 8, 29, 57, and 85
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
Related trials for Seasonal Allergic Rhinitis
RecruitingPhase 1
Safety, Tolerability And Pharmacodynamics of DM-101PX in Birch Pollen Allergy
Birch Pollen Allergy
Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
Enrolling by invitationObservational study
Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
Pollen Allergy
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Recruiting
Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis (SAR), Allergic Rhinitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
General Manager study director
Tanabe Pharma Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MT-2990 in people with Seasonal Allergic Rhinitis, run by Tanabe Pharma Corporation at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability as measured by incidence of adverse events (time frame: Up to Day 113). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.