Chronic Spontaneous UrticariaPhase 1NCT06604949
A Study of Single Dose of LP-003 in Healthy Adult Subjects
A Phase 1 study testing LP-003 200mg in people with Chronic Spontaneous Urticaria, run by Longbio Pharma at 1 site in China.
Trial summary
The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-003 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Spontaneous Urticaria
- What is being tested?
- LP-003 200mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2024to Dec 2026
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or females aged ≥18 and ≤ 50 years.
- Male subjects must weigh ≥50 kg, and female subjects must weigh ≥45 kg, with a BMI between 19.0 and 28.0 kg/m² (inclusive).
- Male subjects and their partners or female subjects must agree to use one or more non-pharmaceutical contraceptive methods (such as total abstinence, condoms, Iuds, partner ligation, etc.) during the trial period and for 6 months after the trial, and do not plan to donate sperm or eggs.
- The subjects fully understand the purpose, nature, method and possible adverse reactions of the experiment, and voluntarily participate in the experiment and sign the informed consent.
- The subjects were able to communicate well with the researchers and complete the study according to the protocol.
Who cannot join
- People who are allergic to the experimental drug and any of its excipients, have a history of allergy to monoclonal antibodies, and are allergic to multiple drugs and food.
- Patients who have been or are currently suffering from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatric and metabolic abnormalities, or any other diseases that can interfere with the test results.
- Patients who had undergone surgery within 3 months before the trial that the researchers judged would affect drug absorption, distribution, metabolism, and excretion, or had surgery within 4 weeks prior to the trial, or planned to have surgery during the study period.
- Any history of infection within 14 days prior to administration.
- A person who is currently infected with parasites or has traveled to an endemic area within the last 3 months or 24 weeks prior to administration.
- Pregnant and lactating women.
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- Hepatitis B surface antigen, hepatitis C virus antibodies, human immunodeficiency virus antibodies, treponema pallidum antibodies A positive person.
- Patients who have received any biological agent (including antibodies or derivatives such as omazumab) within 16 weeks prior to administration (or 5 half-lives, selecting the longer time period).
- Participants who had participated in other clinical trials within 3 months prior to screening.
- The investigator deems any condition unsuitable for study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Dose of LP-003 in Healthy Adult Subjects
The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-003 in healthy subjects.
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- LP-003 200mg, Placebo
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LP-003 200mgDrug
Subcutaneous injection of 200 mg LP-003
PlaceboDrug
Subcutaneous injection of placebo
| Study group | Role | What they receive |
|---|---|---|
| LP-003 | Experimental | Single dose administration, with a dosage of 200 mg LP-003 Receives: Drug: LP-003 200mg |
| Placebo | Placebo comparator | Single dose administration of LP-003 placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AE)
Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 12 months
Secondary outcomes (3)
Area under the concentration-time curve from the first dose to the last measurable concentration time (AUC0-t)
Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 12 months
The proportion of ADA (Anti Drug Antibody) positive subjects
Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 12 months
Serum total IgE and free IgE levels compared to baseline
Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start23 Oct 2024
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous UrticariaStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Longbio Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604949
- Sponsor's protocol ID
- P10-LP003-07
- Status last verified
- Dec 2025
- First submitted
- 14 Sep 2024
- Last updated
- 18 Dec 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 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Dose of LP-003 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06604949
- Acronym / sponsor ID
- P10-LP003-07
- Conditions
- Chronic Spontaneous Urticaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Longbio PharmaIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Sep 2024 (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.
The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-003 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LP-003 | Experimental | Drug: LP-003 200mgSingle dose administration, with a dosage of 200 mg LP-003 |
| Placebo | Placebo comparator | Drug: PlaceboSingle dose administration of LP-003 placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy males or females aged ≥18 and ≤ 50 years.
- Male subjects must weigh ≥50 kg, and female subjects must weigh ≥45 kg, with a BMI between 19.0 and 28.0 kg/m² (inclusive).
- Male subjects and their partners or female subjects must agree to use one or more non-pharmaceutical contraceptive methods (such as total abstinence, condoms, Iuds, partner ligation, etc.) during the trial period and for 6 months after the trial, and do not plan to donate sperm or eggs.
- The subjects fully understand the purpose, nature, method and possible adverse reactions of the experiment, and voluntarily participate in the experiment and sign the informed consent.
- The subjects were able to communicate well with the researchers and complete the study according to the protocol.
Key exclusion criteria (10 listed)
- People who are allergic to the experimental drug and any of its excipients, have a history of allergy to monoclonal antibodies, and are allergic to multiple drugs and food.
- Patients who have been or are currently suffering from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatric and metabolic abnormalities, or any other diseases that can interfere with the test results.
- Patients who had undergone surgery within 3 months before the trial that the researchers judged would affect drug absorption, distribution, metabolism, and excretion, or had surgery within 4 weeks prior to the trial, or planned to have surgery during the study period.
- Any history of infection within 14 days prior to administration.
- A person who is currently infected with parasites or has traveled to an endemic area within the last 3 months or 24 weeks prior to administration.
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 200mgSubcutaneous injection of 200 mg LP-003 | Drug | LP-003 |
| PlaceboSubcutaneous injection of placebo | Drug | Placebo |
Primary outcome
Incidence of adverse events (AE)
Time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 12 months
3 secondary outcomes
Area under the concentration-time curve from the first dose to the last measurable concentration time (AUC0-t)
Time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 12 months
The proportion of ADA (Anti Drug Antibody) positive subjects
Time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 12 months
Serum total IgE and free IgE levels compared to baseline
Time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 12 months
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 18 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
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 LP-003 200mg in people with Chronic Spontaneous Urticaria, 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 5 inclusion and 10 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 18 Dec 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 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. 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?
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?
Incidence of adverse events (AE) (time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 12 months). 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 18 Dec 2025.