A Study of Single Dose of LP-003 in Healthy Adult Subjects

Longbio Pharma

Status and phase: Not yet enrolling; Phase 1

Conditions: Chronic Spontaneous Urticaria

Treatments: Drug: Placebo; Drug: LP-003 200mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06604949

P10-LP003-07

Details and patient eligibility

About

The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-003 in healthy subjects.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy males or females aged ≥18 and ≤ 50 years.
2. 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).
3. 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.
4. 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.
5. The subjects were able to communicate well with the researchers and complete the study according to the protocol.

Exclusion criteria

1. 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.
2. 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.
3. 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.
4. Any history of infection within 14 days prior to administration.
5. 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.
6. Pregnant and lactating women.
7. Hepatitis B surface antigen, hepatitis C virus antibodies, human immunodeficiency virus antibodies, treponema pallidum antibodies A positive person.
8. 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).
9. Participants who had participated in other clinical trials within 3 months prior to screening.
10. The investigator deems any condition unsuitable for study participation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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12 participants in 2 patient groups, including a placebo group

LP-003

Experimental group

Description:

Single dose administration, with a dosage of 200 mg LP-003

Treatment:

Drug: LP-003 200mg

Placebo

Placebo Comparator group

Description:

Single dose administration of LP-003 placebo

Treatment:

Drug: Placebo