Allergic RhinitisPhase 1/2NCT04088721
Tolerability and Potential Efficacy of AD17002 in Subjects With Allergic Rhinitis
A Phase 1/2 study testing AD17002 and Formulation Buffer in people with Allergic Rhinitis, run by Advagene Biopharma Co. Ltd. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 49 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- AD17002 and Formulation Buffer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Mar 2019to 11 Dec 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Has a known history of allergy (except HDM), hypersensitivity, or intolerance to investigational medicinal products, rescue medications, or self-injectable epinephrine.
- Subjects with chronic (> 6 months) or intermittent dependence on nasal, inhaled, oral, intramuscular, intravenous corticosteroids, or potent topical corticosteroids with systemic effects. Subjects who are non-chronic users and do not use these corticosteroids intermittently must undergo at least 5 half-lives of washout prior to the Screening visit.
- Subjects using other medications for their allergic rhinitis and/or asthma if they cannot abstain from the specified time window below (or 5 half-lives, whichever is longer) prior to the Screening visit:
- Nasal or oral antihistamines: 48 hours
- Nasal decongestants: 24 hours
- Oral decongestants: 24 hours
- Short acting inhaled beta-agonists: 48 hours
- Long acting antihistamine (half-life >24hrs): 10 days
- Subjects who had chronic use (> 6 months) of concomitant medications [e.g., tricyclic antidepressants, beta-blocker, xanthines (including theophylline, but not including caffeine), anticholinergics, cromoglycates, leukotriene antagonists, 5-lipoxygenase inhibitors and long-acting inhaled beta-agonists, etc] that would affect assessment of the effectiveness of the investigational product. Subjects who are non-chronic users of these medications must undergo at least 5 half-lives of washout prior to the Screening visit.
- Is nursing at randomization and within the projected duration of the trial.
- Subject who plans travel outside the trial area for a substantial portion of the trial period.
- Other cases judged by the investigator to be ineligible for participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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:
- 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.
- 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.
- 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
- Allergic Rhinitis
- Being tested
- AD17002, Formulation Buffer
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD17002Biological
LTh(αK) as immunomodulator
Formulation BufferOther
Formulation buffer
| Study group | Role | What they receive |
|---|---|---|
| AD17002 20μg | Experimental | Intranasal weekly dosing of AD17002 for three times Receives: Biological: AD17002 |
| AD17002 40μg | Experimental | Intranasal weekly dosing of AD17002 for three times Receives: Biological: AD17002 |
| AD17002 60μg | Experimental | Intranasal weekly dosing of AD17002 for three times Receives: Biological: AD17002 |
| Placebo | Placebo comparator | Intranasal weekly dosing (placebo) for three times Receives: Other: Formulation Buffer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 51 days.
Secondary outcomes (5)
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)
Measured: 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.
Measured: 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.
Measured: 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).
Measured: up to 51 days.
Change in the titers of Drug specific antibodies.
The titers of specific antibodies, IgA, IgE and IgG, are measured by ImmunoCap methods(Phadia 100).
Measured: up to 51 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start26 Mar 2019
- Primary completion30 Jul 2020
- Study completion11 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advagene Biopharma Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinipace Worldwide, Taipei Medical University
- Responsible party
- Sponsor
- Investigators
- Hanpin Kuo, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088721
- Sponsor's protocol ID
- AD17002-AI01
- Status last verified
- Sep 2021
- First submitted
- 8 Aug 2019
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04088721
- Acronym / sponsor ID
- AD17002-AI01
- Conditions
- Allergic Rhinitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Advagene Biopharma Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Clinipace Worldwide, Taipei Medical University
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 13 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AD17002 20μg | Experimental | Biological: AD17002Intranasal weekly dosing of AD17002 for three times |
| AD17002 40μg | Experimental | Biological: AD17002Intranasal weekly dosing of AD17002 for three times |
| AD17002 60μg | Experimental | Biological: AD17002Intranasal weekly dosing of AD17002 for three times |
| Placebo | Placebo comparator | Other: Formulation BufferIntranasal weekly dosing (placebo) for three times |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AD17002LTh(αK) as immunomodulator | Biological | AD17002 20μg, AD17002 40μg, AD17002 60μg |
| Formulation BufferFormulation buffer | Other | Placebo |
Primary outcome
Safety and tolerance of AD17002 treatments in patients with HDM allergy as measured by incidence of adverse events
Time frame: up to 51 days.
* Vital signs * Physical examinations * Safety laboratory parameters (hematology and biochemistry) * Urine parameters * Adverse Events (CTCAE) * Nasal Cavity Examination and Tolerability Symptoms Scoring
5 secondary outcomes
Change in the total nasal symptoms score (TNSS)
Time frame: up to 51 days.
Change in the Rhinitis Daily Medication use Score (DMS)
Time frame: up to 51 days.
Change in the the average of subject-reported combined TNSS and DMS
Time frame: up to 51 days.
Change in the titers of HDM specific antibodies
Time frame: up to 51 days.
Change in the titers of Drug specific antibodies.
Time frame: up to 51 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanpin Kuo principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AD17002 and Formulation Buffer in people with Allergic Rhinitis, run by Advagene Biopharma Co. Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerance of AD17002 treatments in patients with HDM allergy as measured by incidence of adverse events (time frame: up to 51 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.