Tolerability and Potential Efficacy of AD17002 in Subjects With Allergic Rhinitis

NCT04088721 | Completed Phase 1

• 1 other identifier: AD17002-AI01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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

  up to 51 days.

Secondary Outcomes (5)

• Change in the total nasal symptoms score (TNSS)

  up to 51 days.

• Change in the Rhinitis Daily Medication use Score (DMS)

  up to 51 days.

• Change in the the average of subject-reported combined TNSS and DMS

  up to 51 days.

• Change in the titers of HDM specific antibodies

  up to 51 days.

• Change in the titers of Drug specific antibodies.

  up to 51 days.

Study Arms (4)

AD17002 20μg

EXPERIMENTAL

Intranasal weekly dosing of AD17002 for three times

Biological: AD17002

AD17002 40μg

EXPERIMENTAL

Intranasal weekly dosing of AD17002 for three times

Biological: AD17002

AD17002 60μg

EXPERIMENTAL

Intranasal weekly dosing of AD17002 for three times

Biological: AD17002

Placebo

PLACEBO COMPARATOR

Intranasal weekly dosing (placebo) for three times

Other: Formulation Buffer

Interventions

AD17002 BIOLOGICAL

LTh(αK) as immunomodulator

AD17002 20μg; AD17002 40μg; AD17002 60μg

Formulation Buffer OTHER

Formulation buffer

Placebo

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A subject can participate in the study only if all the following criteria are met:
• Subject 20-49 aged years, having a clinical history of allergic rhinitis (diagnosed by a physician) of 1 year duration or more and have received anti-allergy treatment during the previous year before the study enrollment.
• Subjects with HDM-specific IgE serum value ≥ 0.7 kUA/L during screening period.
• HDM allergic rhinitis symptoms during the baseline period defined as a total nasal symptoms score more than 6, at least on 5 of 7 consecutive calendar days in screening period. A subject receiving anti-allergy medication is required to washout of their medication before and during screening period of the trial until the required symptom threshold is met.
• No known prior clinical history of asthma.
• Subjects who are of reproductive potential agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control within the projected duration of the trial. Acceptable methods of birth control are: intrauterine device, hormonal contraception, diaphragm with spermicide, contraceptive sponge, condom, vasectomy, as per local regulations or guidelines. Female subjects of childbearing potential must have negative serum pregnancy test at screening, and negative urine pregnancy test at randomization visit.
• A female subject who is not of reproductive potential and a male subject who is diagnosed to be sterile is eligible without requiring the use of contraception. A female subject who is not of reproductive potential is defined as: one who has either
• Reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone levels in the postmenopausal range as determined by the laboratory, or 12 months of spontaneous amenorrhea),
• Six weeks postsurgical documented total hysterectomy and/or bilateral salpingo-oophorectomy, or
• Bilateral tubal ligation.
• Subject or the subject's legal representative understands the trial procedures, alternative treatments available, risks involved with the trial, and voluntarily agrees to participate by giving written informed consent.
• Be able to read, understand, and complete questionnaires and diaries.
• Provide written informed consent for the trial and willing to adhere to dose and visit schedules.

You may not qualify if:

• Subjects who meet any of the following criteria are not eligible to enter the study:
• Has a clinically relevant, known history of symptomatic allergic rhinoconjunctivitis and/or asthma caused by mold, animal hair and dander, or other allergens (except HDM) to which the subject is regularly exposed and sensitized. Subjects without a known history of allergy other than to HDM, but show any positive result (on CAP test) towards the allergens could be accepted in the judgement of the investigator.
• Has any nasal condition that, in the judgement of the investigator, could confound the efficacy or safety assessments (e.g., nasal polyposis, nasal malformation, frequent nosebleeds, etc).
• Has a history of anaphylaxis reaction to any known or unknown cause.
• Has a history of chronic urticaria and/or angioedema within the last 2 years before Screening Visit.
• Immunosuppressed subjects as result of illness (e.g. HIV infection) or treatment.
• Has acute respiratory illness needing antibiotics or antivirals within 14 days prior to the Screening visit.
• Has acute sinusitis or chronic sinusitis accompanying acute symptoms within 3 days prior to administration of first dose of study drug.
• Has any clinically relevant chronic disease (≥3 months duration) \[including but not limited to cystic fibrosis, malignancy, type I diabetes mellitus, malabsorption or malnutrition, renal or hepatic insufficiency, rheumatic arthritis, lupus and other autoimmune diseases\].
• Has documented history of Bell's palsy.
• Has a history of allergic reaction to kanamycin.
• Has received Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the Screening visit.
• Has had previous immunotherapy treatment with any HDM allergen.
• Has had previous exposure to the study drug or Flu Vaccine AD07030.
• Is receiving ongoing treatment with any specific immunotherapy at the time of the Screening Visit.

Sponsors & Collaborators

• Advagene Biopharma Co. Ltd.: lead
• Clinipace Worldwide: collaborator
• Taipei Medical University: collaborator

Study Sites (1)

Taipei Medical University

Taipei, Taiwan, Taiwan

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

heat-labile enterotoxin, E coli

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Hanpin Kuo

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: September 13, 2019
• Study Start: March 26, 2019
• Primary Completion: July 30, 2020
• Study Completion: December 11, 2020
• Last Updated: September 16, 2025

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)