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NCT Number: NCT03570957

A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients

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.

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Key information

Conditions

Seasonal Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MT-2990

Drug

MT-2990 solution for injection in vial

Placebo

Drug

Placebo solution for injection in vial

Primary outcomes

  1. Safety and tolerability as measured by incidence of adverse events

    Time frame: Up to Day 113

  2. Proportion of subjects who develop antibodies against MT-2990 in serum

    Time frame: Up to Day 113

Secondary outcomes

  1. MT-2990 concentration in serum

    Time frame: Up to Day 113

  2. Maximum observed serum concentration (Cmax) of MT-2990

    Time frame: Up to Day 113

  3. Measured time of maximum observed serum concentration (tmax) of MT-2990

    Time frame: Up to Day 113

  4. Apparent terminal elimination half-life (t1/2) of MT-2990

    Time frame: Up to Day 113

  5. AUC from time zero to the last measurable concentration (AUC0-last) of MT-2990

    Time frame: Up to Day 113

  6. AUC from time zero to infinity (AUC0-∞) of MT-2990

    Time frame: Up to Day 113

  7. Terminal elimination rate constant (kel) of MT-2990

    Time frame: Up to Day 113

  8. Apparent volume of distribution at steady state (Vss) of MT-2990

    Time frame: Up to Day 113

  9. Apparent volume of distribution during terminal phase after IV administration (Vz) of MT-2990

    Time frame: Up to Day 113

  10. Mean residence time from time zero to infinity (MRT0-∞) of MT-2990

    Time frame: Up to Day 113

  11. Apparent serum clearance (CL) of MT-2990

    Time frame: Up to Day 113

  12. Percentage of AUC obtained by extrapolation (%AUCex) of MT-2990

    Time frame: Up to Day 113

  13. Total nasal symptom score (TNSS)

    Time frame: 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.

  14. Total ocular symptom score (TOSS)

    Time frame: 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.

  15. Total symptom score (TSS)

    Time frame: Day 8, 29, 57, and 85

    TSS is TNSS plus TOSS.

  16. Change from baseline in TNSS

    Time frame: Day 8, 29, 57, and 85

    Baseline is pre-exposure.

  17. Change from baseline in TOSS

    Time frame: Day 8, 29, 57, and 85

  18. Change from baseline in TSS

    Time frame: Day 8, 29, 57, and 85

  19. Sum of TNSS during allergen exposure in EEC

    Time frame: Day 8, 29, 57, and 85

  20. Sum of TOSS during allergen exposure in EEC

    Time frame: Day 8, 29, 57, and 85

  21. Sum of TSS during allergen exposure in EEC

    Time frame: Day 8, 29, 57, and 85

  22. AUC of TNSS after allergen exposure

    Time frame: Day 8, 29, 57, and 85

  23. AUC of TOSS after allergen exposure

    Time frame: Day 8, 29, 57, and 85

  24. AUC of TSS after allergen exposure

    Time frame: Day 8, 29, 57, and 85

  25. Proportion of subjects with increased TNSS from baseline

    Time frame: Day 8, 29, 57, and 85

  26. Proportion of subjects with increased TOSS from baseline

    Time frame: Day 8, 29, 57, and 85

  27. Proportion of subjects with increased TSS from baseline

    Time frame: Day 8, 29, 57, and 85

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients (Single Dose Study)

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 27, 2018
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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