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Clinical trial

Tolerability and Potential Efficacy of LTh(??) in Subjects With Allergic Rhinitis

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Last updated:26th Mar 2019
Identifier: NCT04088721

Brief Summary:
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.

Detailed Description:
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.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 48 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date: March 26, 2019
Estimated Primary Completion Date: September 30, 2020
Estimated Study Completion Date: December 31, 2020

Arms:
- Experimental:
AD17002 20μg
- Experimental: AD17002 40μg
- Experimental: AD17002 60μg
- Placebo Comparator: Placebo

Category Value
Date last updated at source 2019-09-13
Study type(s) Interventional
Expected enrolment 48
Study start date 2019-03-26
Estimated primary completion date 2020-09-30

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