BridgeMD
Tests treatment safety and results for Allergen Immunotherapy
Official title 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
ClinicalTrials.gov ID: NCT07726147
What this study is testing
What is ITI-9001?
ITI-9001 is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for allergen immunotherapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 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
You likely can't join if
- Women of childbearing potential (do not meet inclusion criterion #2)
- Respiratory function: \ a. Fever ≥38°C (100.4°F) on day of study drug administration \ b. FEV1 \ c. Current smoker/tobacco user \ d. History of...
- Contraindications: \ a. Known allergy to ITI-9001 components \ b. Contraindication to intramuscular injections or blood draws \ c. History of...
- Prior/concurrent treatments: \ a. Participation in another therapeutic clinical trial within 30 days before screening \ b. Prior or current...
- Medical history/comorbidities: \ a. Clinically significant abnormalities on physical exam, labs, or medical history that jeopardize safety or...
See the full eligibility criteria
- 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...
- 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: \ a. Women of non-childbearing potential: negative serum pregnancy test ≤3 days before first dose \ b. Men: surgically sterile, or agree to abstinence or use 2 highly effective methods of...
- 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...
- Willing and able to participate and comply with all study procedures
- Women of childbearing potential (do not meet inclusion criterion #2)
- Respiratory function: \ a. Fever ≥38°C (100.4°F) on day of study drug administration \ b. FEV1 \ c. Current smoker/tobacco user \ d. History of asthma requiring daily medication (except exercise-induced or mild...
- Contraindications: \ a. Known allergy to ITI-9001 components \ b. Contraindication to intramuscular injections or blood draws \ c. History of intolerance or severe allergic reaction to previous immunotherapy \ d...
- Prior/concurrent treatments: \ a. Participation in another therapeutic clinical trial within 30 days before screening \ b. Prior or current immunotherapy for JCP \ c. Specific or nonspecific immunotherapy within 1 year...
- Medical history/comorbidities: \ 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)...
The study team makes the final eligibility decision.
Where it's taking place
- Tokyo, Shinjuku-ku, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 months to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tokyo, Shinjuku-ku, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.