Trials / Completed
CompletedNCT04088721
Tolerability and Potential Efficacy of AD17002 in Subjects With Allergic Rhinitis
A Ib/IIa Randomized, Placebo Controlled, Intranasal Administration Study on Safety, Tolerability and Potential Efficacy of AD17002 in Subjects With House Dust Mite (HDM) Allergic Rhinitis
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Advagene Biopharma Co. Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 49 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AD17002 | LTh(αK) as immunomodulator |
| OTHER | Formulation Buffer | Formulation buffer |
Timeline
- Start date
- 2019-03-26
- Primary completion
- 2020-07-30
- Completion
- 2020-12-11
- First posted
- 2019-09-13
- Last updated
- 2025-09-16
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT04088721. Inclusion in this directory is not an endorsement.