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

Seasonal Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03570957
• Other study ID #: MT-2990-J01
• Status: Completed
• Phase: Phase 1
• Start date: July 17, 2018
• Est. completion date: December 27, 2018

Study information

• Verified date: January 2019
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 27, 2018
• Est. primary completion date: December 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• MT-2990
MT-2990 solution for injection in vial
• Placebo
Placebo solution for injection in vial

Locations

Country	Name	City	State
Japan	Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability as measured by incidence of adverse events		Up to Day 113
Primary	Proportion of subjects who develop antibodies against MT-2990 in serum		Up to Day 113
Secondary	MT-2990 concentration in serum		Up to Day 113
Secondary	Maximum observed serum concentration (Cmax) of MT-2990		Up to Day 113
Secondary	Measured time of maximum observed serum concentration (tmax) of MT-2990		Up to Day 113
Secondary	Apparent terminal elimination half-life (t1/2) of MT-2990		Up to Day 113
Secondary	AUC from time zero to the last measurable concentration (AUC0-last) of MT-2990		Up to Day 113
Secondary	AUC from time zero to infinity (AUC0-8) of MT-2990		Up to Day 113
Secondary	Terminal elimination rate constant (kel) of MT-2990		Up to Day 113
Secondary	Apparent volume of distribution at steady state (Vss) of MT-2990		Up to Day 113
Secondary	Apparent volume of distribution during terminal phase after IV administration (Vz) of MT-2990		Up to Day 113
Secondary	Mean residence time from time zero to infinity (MRT0-8) of MT-2990		Up to Day 113
Secondary	Apparent serum clearance (CL) of MT-2990		Up to Day 113
Secondary	Percentage of AUC obtained by extrapolation (%AUCex) of MT-2990		Up to Day 113
Secondary	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
Secondary	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
Secondary	Total symptom score (TSS)	TSS is TNSS plus TOSS.	Day 8, 29, 57, and 85
Secondary	Change from baseline in TNSS	Baseline is pre-exposure.	Day 8, 29, 57, and 85
Secondary	Change from baseline in TOSS		Day 8, 29, 57, and 85
Secondary	Change from baseline in TSS		Day 8, 29, 57, and 85
Secondary	Sum of TNSS during allergen exposure in EEC		Day 8, 29, 57, and 85
Secondary	Sum of TOSS during allergen exposure in EEC		Day 8, 29, 57, and 85
Secondary	Sum of TSS during allergen exposure in EEC		Day 8, 29, 57, and 85
Secondary	AUC of TNSS after allergen exposure		Day 8, 29, 57, and 85
Secondary	AUC of TOSS after allergen exposure		Day 8, 29, 57, and 85
Secondary	AUC of TSS after allergen exposure		Day 8, 29, 57, and 85
Secondary	Proportion of subjects with increased TNSS from baseline		Day 8, 29, 57, and 85
Secondary	Proportion of subjects with increased TOSS from baseline		Day 8, 29, 57, and 85
Secondary	Proportion of subjects with increased TSS from baseline		Day 8, 29, 57, and 85