Allergic DiseasesPhase 1/2NCT07148557
A Study of Single Dose of LP-003 in Adolescent Subjects
A Phase 1/2 study testing LP-003 Dose 1 (Single) and LP-003 Dose 2 (Single) in people with Allergic Diseases, run by Longbio Pharma at 1 site in China.
Trial summary
This is a single-center, open-label, phase Ib clinical study to evaluate the safety, pharmacokinetics and pharmacodynamic characteristics of LP-003 injection in adolescent subjects aged 12-18 years. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Diseases
- What is being tested?
- LP-003 Dose 1 (Single) and LP-003 Dose 2 (Single)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 30 Sep 2026
- Phase
- Phase 1/2
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open-label, Phase Ib Clinical Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Characteristics of LP-003 Injection in Adolescent Subjects Aged 12-18 Years
This is a single-center, open-label, phase Ib clinical study to evaluate the safety, pharmacokinetics and pharmacodynamic characteristics of LP-003 injection in adolescent subjects aged 12-18 years.
- Conditions
- Allergic Diseases
- Being tested
- LP-003 Dose 1 (Single), LP-003 Dose 2 (Single)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LP-003 Dose 1 (Single)Biological
A single dose of LP-003 (400 mg/dose) was SC
LP-003 Dose 2 (Single)Biological
A single dose of LP-003 (600 mg/dose) was SC
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: LP-003 Dose 1 (Single) | Experimental | Not described Receives: Biological: LP-003 Dose 1 (Single) |
| Cohort 2 : LP-003 Dose 2 (Single) | Experimental | Not described Receives: Biological: LP-003 Dose 2 (Single) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AE)
Number of subjects with treatment-related Treatment Emergent Adverse Events (TEAEs).
Measured: Observation for 196 days after administration
Secondary outcomes (8)
Time to peak concentration (Tmax) of LP-003
The time when the blood drug concentration reaches its peak after a single dose of medication.
Measured: Observation for 196 days after administration
Maximum concentration (Cmax) of LP-003
The maximum concentration of LP-003 in the bloodstream after administration.
Measured: Observation for 196 days after administration
Elimination half-life (t1/2) of LP-003
The time required for the concentration of LP-003 in the bloodstream to decrease by half.
Measured: Observation for 196 days after administration
Area under the concentration-time curve (AUC0-t) of LP-003
The area under the concentration-time curve (AUC) from time zero to the last chosen time point represents the integral of the drug concentration in the bloodstream over the specified duration.
Measured: Observation for 196 days after administration
Apparent clearance rate (CL/F) of LP-003
The ratio of drug clearance to drug concentration, represents the apparent clearance of a drug after administration, adjusted for bioavailability.
Measured: Observation for 196 days after administration
Assessment of total immunoglobulin E (IgE)
The changes in serum total IgE levels compared to baseline at different assessment time points.
Measured: Observation for 196 days after administration
Assessment of free immunoglobulin E (IgE)
The changes in serum free IgE levels compared to baseline at different assessment time points.
Measured: Observation for 196 days after administration
Assessment of immunogenicity
The proportion of anti drug antibody (ADA) positive subjects at different detection time points.
Measured: Observation for 196 days after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 Oct 2025
- Primary completion31 May 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic DiseasesStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Longbio Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huan Zhou, Principal investigator, The First Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148557
- Sponsor's protocol ID
- P10-LP003-09
- Status last verified
- Feb 2026
- First submitted
- 15 Aug 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Phase Ib Clinical Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Characteristics of LP-003 Injection in Adolescent Subjects Aged 12-18 Years
- ClinicalTrials.gov ID
- NCT07148557
- Acronym / sponsor ID
- P10-LP003-09
- Conditions
- Allergic Diseases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Longbio PharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 29 Aug 2025 (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 single-center, open-label, phase Ib clinical study to evaluate the safety, pharmacokinetics and pharmacodynamic characteristics of LP-003 injection in adolescent subjects aged 12-18 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: LP-003 Dose 1 (Single) | Experimental | Biological: LP-003 Dose 1 (Single) |
| Cohort 2 : LP-003 Dose 2 (Single) | Experimental | Biological: LP-003 Dose 2 (Single) |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| LP-003 Dose 1 (Single)A single dose of LP-003 (400 mg/dose) was SC | Biological | Cohort 1: LP-003 Dose 1 (Single) |
| LP-003 Dose 2 (Single)A single dose of LP-003 (600 mg/dose) was SC | Biological | Cohort 2 : LP-003 Dose 2 (Single) |
Primary outcome
Adverse Events (AE)
Time frame: Observation for 196 days after administration
Number of subjects with treatment-related Treatment Emergent Adverse Events (TEAEs).
8 secondary outcomes
Time to peak concentration (Tmax) of LP-003
Time frame: Observation for 196 days after administration
Maximum concentration (Cmax) of LP-003
Time frame: Observation for 196 days after administration
Elimination half-life (t1/2) of LP-003
Time frame: Observation for 196 days after administration
Area under the concentration-time curve (AUC0-t) of LP-003
Time frame: Observation for 196 days after administration
Apparent clearance rate (CL/F) of LP-003
Time frame: Observation for 196 days after administration
Assessment of total immunoglobulin E (IgE)
Time frame: Observation for 196 days after administration
Assessment of free immunoglobulin E (IgE)
Time frame: Observation for 196 days after administration
Assessment of immunogenicity
Time frame: Observation for 196 days after administration
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 17 Feb 2026.
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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.
Huan Zhou principal investigator
The First Affiliated Hospital of Anhui 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 LP-003 Dose 1 (Single) and LP-003 Dose 2 (Single) in people with Allergic Diseases, run by Longbio Pharma at 1 site in China.
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 4 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 17 Feb 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 China. 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. 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?
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?
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?
Adverse Events (AE) (time frame: Observation for 196 days after administration). 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 17 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.