Allergen ImmunotherapyPhase 1NCT07726147
Phase 1, First in Human (FIH), Open-Label, Single-Arm, Ascending Dose Study to Assess the Safety, Tolerability and Preliminary Immunogenicity of ITI-9001 in Japanese Patients With Japanese Red Cedar (JRC) Pollinosis
A Phase 1 study testing ITI-9001 in people with Allergen Immunotherapy, run by Immunomic Therapeutics, Inc. at 1 site in Japan.
Trial summary
This is a Phase 1, first-in-human clinical trial to test a new treatment called ITI-9001 for people with allergies to Japanese Red Cedar (JRC) pollen-a common cause of seasonal allergies in Japan. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergen Immunotherapy
- What is being tested?
- ITI-9001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteJapan
- Study dates
- 20 Jun 2026to Feb 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent form (ICF)
- Female of non-childbearing potential or male aged 18-65 years (inclusive). Women are not considered to be of childbearing potential if they have had a hysterectomy or tubal ligation, or are postmenopausal (≥12 months without menstruation, or FSH in postmenopausal range for women <55 years)
- Confirmed JCP sensitivity by positive skin prick test (wheal diameter ≥3 mm)
- Confirmed JCP sensitivity by ImmunoCAP (serum JCP-specific IgE ≥ class 2)
- ≥2 year history of seasonal rhinoconjunctivitis symptoms requiring medication upon JCP exposure
- Contraception requirements: <br> a. Women of non-childbearing potential: negative serum pregnancy test ≤3 days before first dose <br> b. Men: surgically sterile, or agree to abstinence or use 2 highly effective methods of contraception during study and for 3 months after last dose if partner is of childbearing potential (male condom + oral hormonal contraceptives, intrauterine device, or intrauterine hormone-releasing system)
- No significant ischemic heart disease or myocardial infarction within 6 months before first study drug administration; adequate cardiac function at screening (QTcF ≤470 msec for females or ≤450 msec for males; average of triplicate ECGs). Participants with ventricular arrhythmia assessed case-by-case
- Willing and able to participate and comply with all study procedures
Who cannot join
- Women of childbearing potential (do not meet inclusion criterion #2)
- Respiratory function: <br> a. Fever ≥38°C (100.4°F) on day of study drug administration <br> b. FEV1 <80% as predicted on spirometry <br> c. Current smoker/tobacco user <br> d. History of asthma requiring daily medication (except exercise-induced or mild intermittent asthma)
- Contraindications: <br> a. Known allergy to ITI-9001 components <br> b. Contraindication to intramuscular injections or blood draws <br> c. History of intolerance or severe allergic reaction to previous immunotherapy <br> d. History of anaphylaxis requiring medical intervention (including severe reactions to mRNA vaccines)
- Prior/concurrent treatments: <br> a. Participation in another therapeutic clinical trial within 30 days before screening <br> b. Prior or current immunotherapy for JCP <br> c. Specific or nonspecific immunotherapy within 1 year prior to screening <br> d. Biologics (e.g., anti-IgE, anti-IL-5, anti-TNFα) <br> e. mRNA vaccine within 28 days before first study drug administration <br> f. Live vaccine within 28 days or inactivated/toxoid vaccine within 7 days before first study drug administration <br> g. Chronic (more than 30 days) systemic corticosteroids (inhaled, oral, IM, IV, potent topical) <br> h. Inability/unwillingness to discontinue beta-blockers up to 48 hours before first study drug administration and during the study <br> i. Inability/unwillingness to comply with washout periods for antihistamines and other allergy medications (per Table 3)
- Medical history/comorbidities: <br> a. Clinically significant abnormalities on physical exam, labs, or medical history that jeopardize safety or validity of results (except HEENT findings consistent with allergic rhinitis) <br> b. Malignant tumor diagnosed or treated within 5 years prior to first study drug administration (except adequately treated non-melanoma skin cancer or carcinoma in situ) <br> c. Congenital or acquired immune deficiency or suppression (e.g., malignancy, infection, chemotherapy, radiation, corticosteroids) <br> d. History of organ transplant, hematologic malignancy, or autoimmune disease <br> e. History of stroke, transient ischemic attack, unstable angina, myocardial infarction within 3 months prior to first study drug administration <br> f. Symptomatic congestive heart failure (NYHA Class III-IV), unstable angina, significant arrhythmia, or LVEF <45% <br> g. History of myocarditis or pericarditis <br> h. Risk factors for torsades de pointes or use of medications known to prolong QT/QTc (except low-risk premedications) <br> i. Clinically significant gastrointestinal, renal, hepatic, neurologic, or hematologic disease <br> j. HIV/AIDS, hepatitis B, or hepatitis C infection <br> k. Recurrent sinusitis, urticaria, or angioedema within past 12 months prior to first study drug administration <br> l. Symptomatic overlap with JRC pollinosis requiring regular medications <br> m. Alcohol or drug abuse within 1 year before screening or current dependence
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Medical Corporation Shinanokai SHINANOZAKA Clinic
Tokyo, Shinjuku-ku
About this study
Official title: Phase 1, First in Human (FIH), Ascending Dose Study to Assess the Safety, Tolerability and Preliminary Immunogenicity of ITI-9001 in Japanese Patients With Japanese Red Cedar (JRC) Pollinosis: A Two-part Design Consisting of an Open-Label, Single-Arm Part A and a Randomized, Double-Blind, Part B
This is a Phase 1, first-in-human clinical trial to test a new treatment called ITI-9001 for people with allergies to Japanese Red Cedar (JRC) pollen-a common cause of seasonal allergies in Japan. The main goals are to find out if ITI-9001 is safe, how well people tolerate it, and whether it can trigger helpful immune responses.
Read the detailed description
Phase I, open-label, single-arm, ascending dose study to evaluate the safety, tolerability, and preliminary immunogenicity of ITI-9001. The study will be conducted in 2 parts -Part A and Part B.
Part A is a 'dose escalation' phase where two different doses will be given (a low dose and a high dose), where the total duration of study participation for each patient will be approximately 6 months.
Part B is an 'expansion' phase using the highest tolerated dose from Part A, where a total duration of study participation for each patient will be approximately 12 months if they receive all 3 planned doses and complete all 4 subsequent visits. Part B contains ITI-9001 and a placebo.
- Conditions
- Allergen Immunotherapy
- Being tested
- ITI-9001, Placebo
- Keywords
- Japanese Red Cedar (JRC) pollinosis, Japanese Cedar Pollen (JCP) allergy, seasonal allergic rhinitis, self-amplifying RNA (saRNA)
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITI-9001Drug
ITI-9001 is a self-amplifying RNA (saRNA) immunotherapy formulated with lipid nanoparticles for intramuscular injection. The saRNA encodes a CryJ2-LAMP-1 fusion protein, targeting Japanese Red Cedar (JRC) pollen allergy. ITI-9001 is designed to enhance antigen presentation and stimulate robust immune responses, aiming to reduce allergic symptoms in JCP-sensitive patients.
PlaceboOther
Saline placebo injection
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Part A, ITI-9001 Dose Escalation | Experimental | Part A Eligible participants receive two intramuscular doses of ITI-9001 (either 1 µg or 10 µg) 21 days apart to find maximum tolerated dose. Receives: Drug: ITI-9001 |
| Arm 2, Part B ITI-9001 Dose Expansion | Experimental | Arm 2 of Part B is a double-blind, placebo-controlled group in which eligible Japanese adults with Japanese Red Cedar (JRC) pollinosis receive intramuscular injections of ITI-9001 at the maximum tolerated dose (determined in Arm 1, Part A). Receives: Drug: ITI-9001 |
| Arm 3, Part B Placebo Control | Placebo comparator | Arm 3 of Part B is a double-blind, placebo-controlled group in which eligible Japanese adults with Japanese Red Cedar (JRC) pollinosis receive intramuscular injections of placebo (normal saline) on the same schedule as the ITI-9001, Part B arm Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of dose-limiting toxicities (DLTs)
DLTs will be summarized by frequency and severity from first study drug administration through End of Study (see timeframe below)
Measured: From enrollment to Day 382
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start20 Jun 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergen ImmunotherapyStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This protocol uses an early-phase, interventional, ascending-dose design with a single-arm, open-label safety lead-in (Part A), followed by a randomized, double-blind, placebo-controlled expansion (Part B) to robustly assess safety, tolerability, and preliminary immunogenicity of ITI-9001 in the target population
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunomic Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726147
- Sponsor's protocol ID
- 9001-01-JRC-P1
- Status last verified
- Sep 2026
- First submitted
- 15 Jul 2026
- Last updated
- 25 Sep 2026
- 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, First in Human (FIH), Ascending Dose Study to Assess the Safety, Tolerability and Preliminary Immunogenicity of ITI-9001 in Japanese Patients With Japanese Red Cedar (JRC) Pollinosis: A Two-part Design Consisting of an Open-Label, Single-Arm Part A and a Randomized, Double-Blind, Part B
- ClinicalTrials.gov ID
- NCT07726147
- Acronym / sponsor ID
- 9001-01-JRC-P1
- Conditions
- Allergen Immunotherapy
- Keywords
- Japanese Red Cedar (JRC) pollinosis, Japanese Cedar Pollen (JCP) allergy, seasonal allergic rhinitis, self-amplifying RNA (saRNA)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Immunomic Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 24 Jul 2026 (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.
This is a Phase 1, first-in-human clinical trial to test a new treatment called ITI-9001 for people with allergies to Japanese Red Cedar (JRC) pollen-a common cause of seasonal allergies in Japan. The main goals are to find out if ITI-9001 is safe, how well people tolerate it, and whether it can trigger helpful immune responses.
Detailed description
Phase I, open-label, single-arm, ascending dose study to evaluate the safety, tolerability, and preliminary immunogenicity of ITI-9001. The study will be conducted in 2 parts -Part A and Part B.
Part A is a 'dose escalation' phase where two different doses will be given (a low dose and a high dose), where the total duration of study participation for each patient will be approximately 6 months.
Part B is an 'expansion' phase using the highest tolerated dose from Part A, where a total duration of study participation for each patient will be approximately 12 months if they receive all 3 planned doses and complete all 4 subsequent visits. Part B contains ITI-9001 and a placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This protocol uses an early-phase, interventional, ascending-dose design with a single-arm, open-label safety lead-in (Part A), followed by a randomized, double-blind, placebo-controlled expansion (Part B) to robustly assess safety, tolerability, and preliminary immunogenicity of ITI-9001 in the target population
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Part A, ITI-9001 Dose Escalation | Experimental | Drug: ITI-9001Part A Eligible participants receive two intramuscular doses of ITI-9001 (either 1 µg or 10 µg) 21 days apart to find maximum tolerated dose. |
| Arm 2, Part B ITI-9001 Dose Expansion | Experimental | Drug: ITI-9001Arm 2 of Part B is a double-blind, placebo-controlled group in which eligible Japanese adults with Japanese Red Cedar (JRC) pollinosis receive intramuscular injections of ITI-9001 at the maximum tolerated dose (determined in Arm 1, Part A). |
| Arm 3, Part B Placebo Control | Placebo comparator | Other: PlaceboArm 3 of Part B is a double-blind, placebo-controlled group in which eligible Japanese adults with Japanese Red Cedar (JRC) pollinosis receive intramuscular injections of placebo (normal saline) on the same schedule as the ITI-9001, Part B arm |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed and dated informed consent form (ICF)
- Female of non-childbearing potential or male aged 18-65 years (inclusive). Women are not considered to be of childbearing potential if they have had a hysterectomy or tubal ligation, or are postmenopausal (≥12 months without menstruation, or FSH in postmenopausal range for women <55 years)
- Confirmed JCP sensitivity by positive skin prick test (wheal diameter ≥3 mm)
- Confirmed JCP sensitivity by ImmunoCAP (serum JCP-specific IgE ≥ class 2)
- ≥2 year history of seasonal rhinoconjunctivitis symptoms requiring medication upon JCP exposure
Key exclusion criteria (5 listed)
- Women of childbearing potential (do not meet inclusion criterion #2)
- Respiratory function: <br> a. Fever ≥38°C (100.4°F) on day of study drug administration <br> b. FEV1 <80% as predicted on spirometry <br> c. Current smoker/tobacco user <br> d. History of asthma requiring daily medication (except exercise-induced or mild intermittent asthma)
- Contraindications: <br> a. Known allergy to ITI-9001 components <br> b. Contraindication to intramuscular injections or blood draws <br> c. History of intolerance or severe allergic reaction to previous immunotherapy <br> d. History of anaphylaxis requiring medical intervention (including severe reactions to mRNA vaccines)
- Prior/concurrent treatments: <br> a. Participation in another therapeutic clinical trial within 30 days before screening <br> b. Prior or current immunotherapy for JCP <br> c. Specific or nonspecific immunotherapy within 1 year prior to screening <br> d. Biologics (e.g., anti-IgE, anti-IL-5, anti-TNFα) <br> e. mRNA vaccine within 28 days before first study drug administration <br> f. Live vaccine within 28 days or inactivated/toxoid vaccine within 7 days before first study drug administration <br> g. Chronic (more than 30 days) systemic corticosteroids (inhaled, oral, IM, IV, potent topical) <br> h. Inability/unwillingness to discontinue beta-blockers up to 48 hours before first study drug administration and during the study <br> i. Inability/unwillingness to comply with washout periods for antihistamines and other allergy medications (per Table 3)
- Medical history/comorbidities: <br> a. Clinically significant abnormalities on physical exam, labs, or medical history that jeopardize safety or validity of results (except HEENT findings consistent with allergic rhinitis) <br> b. Malignant tumor diagnosed or treated within 5 years prior to first study drug administration (except adequately treated non-melanoma skin cancer or carcinoma in situ) <br> c. Congenital or acquired immune deficiency or suppression (e.g., malignancy, infection, chemotherapy, radiation, corticosteroids) <br> d. History of organ transplant, hematologic malignancy, or autoimmune disease <br> e. History of stroke, transient ischemic attack, unstable angina, myocardial infarction within 3 months prior to first study drug administration <br> f. Symptomatic congestive heart failure (NYHA Class III-IV), unstable angina, significant arrhythmia, or LVEF <45% <br> g. History of myocarditis or pericarditis <br> h. Risk factors for torsades de pointes or use of medications known to prolong QT/QTc (except low-risk premedications) <br> i. Clinically significant gastrointestinal, renal, hepatic, neurologic, or hematologic disease <br> j. HIV/AIDS, hepatitis B, or hepatitis C infection <br> k. Recurrent sinusitis, urticaria, or angioedema within past 12 months prior to first study drug administration <br> l. Symptomatic overlap with JRC pollinosis requiring regular medications <br> m. Alcohol or drug abuse within 1 year before screening or current dependence
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 |
|---|---|---|
| ITI-9001ITI-9001 is a self-amplifying RNA (saRNA) immunotherapy formulated with lipid nanoparticles for intramuscular injection. The saRNA encodes a CryJ2-LAMP-1 fusion protein, targeting Japanese Red Cedar (JRC) pollen allergy. ITI-9001 is designed to enhance antigen presentation and stimulate robust immune responses, aiming to reduce allergic symptoms in JCP-sensitive patients. | Drug | Arm 1 - Part A, ITI-9001 Dose Escalation, Arm 2, Part B ITI-9001 Dose Expansion |
| PlaceboSaline placebo injection | Other | Arm 3, Part B Placebo Control |
Primary outcome
Frequency and severity of dose-limiting toxicities (DLTs)
Time frame: From enrollment to Day 382
DLTs will be summarized by frequency and severity from first study drug administration through End of Study (see timeframe below)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ITI-9001 in people with Allergen Immunotherapy, run by Immunomic Therapeutics, Inc. at 1 site in Japan.
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 8 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 25 Sep 2026. 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 Japan. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Scott Wehage, M.S. (301-968-3501, studyinquiries@immunomix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and severity of dose-limiting toxicities (DLTs) (time frame: From enrollment to Day 382). 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 25 Sep 2026.