Clinical trial NCT06294288: A Study of Single and Multiple Doses of LP-003 in Healthy Adult Participants
Official title: To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Single and Multiple Doses of LP-003 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Chronic Spontaneous Urticaria
Lead sponsor: Longbio Pharma
Sponsor class: INDUSTRY
First posted: 2024-03-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-003 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of LP-003 and Part 2, multiple ascending dose (MAD).


Eligibility criteria: Inclusion Criteria:

1. Healthy males or females aged 18 through 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 omalizumab) 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.

Primary outcomes:
measure: Adverse events
timeFrame: Observation for 280 days after administration
Secondary outcomes:
measure: Time to peak concentration (Tmax) of LP-003
timeFrame: Observation for 280 days after administration
measure: Maximum concentration (Cmax) of LP-003
timeFrame: Observation for 280 days after administration
measure: Elimination half-life (t1/2) of LP-003
timeFrame: Observation for 280 days after administration
measure: Area under the concentration-time curve (AUC0-t) of LP-003
timeFrame: Observation for 280 days after administration
measure: Apparent clearance rate (CL/F) of LP-003
timeFrame: Observation for 280 days after administration
measure: Assessment of immunogenicity
timeFrame: Observation for 280 days after administration
measure: Assessment of total immunoglobulin E (IgE)
timeFrame: Observation for 168 days after administration
measure: Assessment of free IgE
timeFrame: Observation for 168 days after administration
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
Study officials:
References: