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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
LTh(αK) as immunomodulator
Formulation buffer
Taipei Medical University
Taipei, Taiwan, Taiwan
Safety and tolerance of AD17002 treatments in patients with HDM allergy as measured by incidence of adverse events
* Vital signs * Physical examinations * Safety laboratory parameters (hematology and biochemistry) * Urine parameters * Adverse Events (CTCAE) * Nasal Cavity Examination and Tolerability Symptoms Scoring
Time frame: up to 51 days.
Change in the total nasal symptoms score (TNSS)
Chang in Sneezing, Rhinorrhea, Nasal congestion / Blockage and Pruritus are recorded in diary and averaged. Severity is graded between 0-3 for each symptom. 0 = no symptoms 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated) 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable) 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping)
Time frame: up to 51 days.
Change in the Rhinitis Daily Medication use Score (DMS)
Antihistamine oral form (Desloratadine 5mg/day) could be used in the evening, if the total reflective TNSS reaches to 8 points or greater. 4 points addition to subjects take the antihistamine and 0 to subjects do not.
Time frame: up to 51 days.
Change in the the average of subject-reported combined TNSS and DMS
Changes in the self-reported TNSS and DMS against baseline.
Time frame: up to 51 days.
Change in the titers of HDM specific antibodies
The titers of specific antibodies, IgA, IgE, IgG and IgG4, are measured by ImmunoCap methods(Phadia 100).
Time frame: up to 51 days.
Change in the titers of Drug specific antibodies.
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The titers of specific antibodies, IgA, IgE and IgG, are measured by ImmunoCap methods(Phadia 100).
Time frame: up to 51 days.