New allergy shot for teens shows early promise
NCT ID NCT07148557
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new injection called LP-003 in 6 teenagers aged 12 to 18 who have allergies like hay fever, asthma, or eczema. The main goal is to check if the drug is safe and how the body processes it. This is an early-stage trial, so it focuses on safety and drug levels rather than how well it treats symptoms.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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6 people
The number who actually took part.
- Started
-
Oct 2025
- Expected to finish
-
Sep 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
12 to 18 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adolescent subjects aged ≥12 years and \<18 years, male or female. * History of allergic diseases (self-reported is acceptable), including, but not limited to, food allergies, allergic rhinitis, allergic asthma, urticaria, and atopic dermatitis. * Agreement to use effective contraception during the study and for 6 months after the end of the study. * Subject and parent or legal guardian able to understand and voluntarily sign the informed consent form, and comply with study visits and related procedures. Exclusion Criteria: * Allergic to LP-003 or its excipients. * Any serious or uncontrolled chronic disease (e.g., severe arrhythmia, ischemic heart disease, NYHA Class III/IV heart failure, severe pulmonary disease, inadequately controlled asthma, hypertension, diabetes, hypo- or hyperthyroidism) that may affect subject safety as determined by the Investigator. * History of severe allergic reactions. * Abnormal venous access, venipuncture or subcutaneous injection intolerance, history of needle or blood phobia. * Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m² at screening. * ALT or AST \> ULN and considered clinically significant by the Investigator. * Any other abnormal screening test result that, in the Investigator's opinion, could affect subject safety or study assessments. * Systemic corticosteroid therapy (intravenous, intramuscular, or oral) within 4 weeks prior to study drug administration. * Use of medications known to interact with epinephrine (e.g., β-blockers, ACE inhibitors, tricyclic antidepressants) within 4 weeks prior to administration. * Use of biologic products (e.g., omalizumab) within 6 months prior to administration. * Receipt vaccines within 14 days before administration or planning vaccination during the study. * Participation in other clinical trials within 3 months prior to screening or within 5 half-lives of investigational product discontinuation (whichever is longer). * Any other conditions that the Investigator considers subjects unsuitable for participation in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
The First Affiliated Hospital of Anhui Medical University
Hefei, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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