Allergic Rhinitis Clinical Trial
Official title:
A Ib/IIa Randomized, Placebo Controlled, Intranasal Administration Study on Safety, Tolerability and Potential Efficacy of LTh(αΚ) in Subjects With House Dust Mite (HDM) Allergic Rhinitis
A single center, double-blind, randomized, dose-escalation study to assess the safety, tolerability and efficacy of 3 doses of AD17002 in comparison to placebo. Subjects will be randomized at 3:1 ratios in each of 3 cohorts to receive AD17002 or placebo.
A single center, double-blind, randomized, dose-escalation study to assess the safety, tolerability and efficacy of 3 doses of AD17002 in comparison to placebo. Subjects will be randomized at 3:1 ratios in each of 3 cohorts to receive AD17002 or placebo. The following treatment cohorts are featured in a dose-escalating manner: A. Cohort 1 will comprise 16 subjects who will receive, in a double-blind manner, either 20 μg AD17002 (n=12) or placebo (n=4) on Study Day 1, 8, and 15. B. Cohort 2 will comprise 16 subjects who will receive, in a double-blind manner, either 40 μg AD17002 (n=12) or placebo (n=4) on Study Day 1, 8, and 15. C. Cohort 3 will comprise 16 subjects who will receive, in a double-blind manner, either 60 μg AD17002 (n=12) or placebo (n=4) on Study Day 1, 8, and 15. A total of 16 subjects in cohort 1 will receive the assigned study preparation before the remainder of the Cohort. Study drug administration to the next subject for the first 8 subjects in the cohort 1 will be separated for at least one day elapse (at least 24 hrs). The progression to the next cohort will take place after the SRT review the whole follow-up period safety data of previous cohort. ;
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