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

NCT03570957 | Completed Phase 1

• 1 other identifier: MT-2990-J01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (27)

• 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

  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

Study Arms (5)

MT-2990, Low dose

EXPERIMENTAL

Single intravenous dose

Drug: MT-2990; Drug: Placebo

MT-2990, Low-middle dose

EXPERIMENTAL

Single intravenous dose

Drug: MT-2990; Drug: Placebo

MT-2990, High-middle dose

EXPERIMENTAL

Single intravenous dose

Drug: MT-2990; Drug: Placebo

MT-2990, High dose

EXPERIMENTAL

Single intravenous dose

Drug: MT-2990

Placebo

PLACEBO COMPARATOR

Single intravenous dose

Drug: Placebo

Interventions

Placebo DRUG

Placebo solution for injection in vial

MT-2990, High-middle dose; MT-2990, Low dose; MT-2990, Low-middle dose; Placebo

MT-2990 DRUG

MT-2990 solution for injection in vial

MT-2990, High dose; MT-2990, High-middle dose; MT-2990, Low dose; MT-2990, Low-middle dose

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Investigational Site

Tokyo, Japan

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

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

Study Officials

• General Manager

  Tanabe Pharma Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: June 27, 2018
• Study Start: July 17, 2018
• Primary Completion: December 27, 2018
• Study Completion: December 27, 2018
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

JP (1)