The study included three phases: the treatment introduction period (4-7 days before randomization), the treatment period (14 days after randomization) and the follow-up period (7 days after the last dose). Eligible participants in this study entered the 4-7 day treatment introduction period. After completing the treatment introduction period, patients who did not meet the random exclusion criteria of this study were randomly assigned to one of the 4 dose cohorts in a 1:1:1:1 ratio, with 80 patients planned to be enrolled in each cohort, and then randomly assigned to receive the investigational product or placebo in the cohort at a 4:1 ratio, for a total of 320 patients. Participants were stratified by prior Drug therapy for Rhinitis allergic. Ultimately, the proportion of patients receiving 200 μg BID, 400 μg BID, 400 μg QD, 800 μg QD and placebo was 1:1:1:1:1 (64 patients in each group).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
370
200 μg BID, 400 μg BID, 400 μg QD, 800 μg QD, 64 patients per cohort, total 256 patients for treatment 14 days
Total 64 patients for treatment 14 days
Beijing Youan Hospital Capital Medical University
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Wuwei People's Hospital
Wuwei, Gansu, China
rTNSS
Change from baseline in mean (AM+PM) rTNSS (reactive nasal symptom total score)
Time frame: During the 14-day treatment period
iTNSS
Change from baseline in mean (AM+PM) ITNSS
Time frame: During the 14-day treatment period
rTOSS
Change from baseline in the mean (AM+PM) rTOSS (reactive eye symptom total score)
Time frame: During the 14-day treatment period
iTOSS
Change from baseline in iTOSS mean (mean of AM and PM)
Time frame: During the 14-day treatment period
AM rTNSS
Change from baseline in AM rTNSS
Time frame: During the 14-day treatment period
AM iTNSS
Change from baseline in AM iTNSS
Time frame: During the 14-day treatment period
PM rTNSS
Change from baseline in PM rTNSS
Time frame: During the 14-day treatment period
PM iTNSS
Change from baseline in PM iTNSS
Time frame: During the 14-day treatment period
AM rTOSS
Change from baseline in AM rTOSS
Time frame: During the 14-day treatment period
AM iTOSS
Change from baseline in AM iTOSS
Time frame: During the 14-day treatment period
PM rTOSS
Change from baseline in PM rTOSS
Time frame: During the 14-day treatment period
PM iTOSS
Change from baseline in PM iTOSS
Time frame: During the 14-day treatment period
Single nasal symptom
Change from baseline in mean value of responsive single nasal symptom (sneezing, Runny nose, nasal itching and nasal congestion) AM and PM
Time frame: During the 14-day treatment period
Single-eye symptoms
Change from baseline in mean reactive single-eye symptoms (itchy/burning eyes, red eyes, tearing)AM and PM
Time frame: During the 14-day treatment period
iTNSS
Evaluation 15 ± 5 min, 30 ± 5 min, 45 ± 5 min, 60 ± 5 min, 90 ± 10 min, 2 h ± 10 min, 4 h ± 0.5 h after the first dose, Change from baseline at 8 ± 0.5 h and 12 ± 0.5 h
Time frame: Within 12 hours of the first dose
RQLQ
Change from baseline in scores on the RQLQ
Time frame: Day 8 and Day 15 after first dose
Safety (Adverse Events)
To evaluate the Adverse Events of JT002 in participants with seasonal allergic rhinitis
Time frame: Through study completion,Estimated 28 days
PK
According to the test of blood samples, Drug concentrations in individual subjects at different time points after dosing
Time frame: Through study completion,Estimated 22 days
Immunogenicity
According to the test of blood samples,to evaluate the incidence and titer of anti-drug antibody (ADA) of JT002
Time frame: Through study completion,Estimated 22 days
Immunogenicity(Nab)
To analyze ADA-positive blood samples for the presence of Neutralizing antibodies (Nab).
Time frame: Through study completion,Estimated 22 days
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Shenzhen Nanshan District People's Hospital
Shenzhen, Guangdong, China
Shenzhen University General Hospital
Shenzhen, Guangdong, China
Zhengzhou Central Hospital
Zhengzhou, Hanan, China
The Second Hospital of Baoding City
Baoding, Hebei, China
Cangzhou Central Hosptial
Cangzhou, Hebei, China
...and 34 more locations