A Study of Single and Multiple Doses of LP-003 in Healthy Adult Participants

To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Single and Multiple Doses of LP-003 in Healthy Volunteers

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Spontaneous Urticaria
• Intervention / Treatment: Biological: Placebo (Single); Biological: Placebo (Multiple); Biological: LP-003 Dose 1 (Single); Biological: LP-003 Dose 2 (Single); Biological: LP-003 Dose 3 (Single); Biological: LP-003 Dose 4 (Single); Biological: LP-003 Dose 5 (Single); Biological: LP-003 Dose 6 (Multiple); Biological: LP-003 Dose 7 (Multiple); Biological: LP-003 Dose 8 (Multiple)

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: LP-003 Dose 1 (Single)	Biological: LP-003 Dose 1 (Single); A single dose of LP-003 (Dose 1) was administered intravenously.
Experimental: Cohort 2: LP-003 Dose 2 (Single)	Biological: LP-003 Dose 2 (Single); A single dose of LP-003 (Dose 2) was administered intravenously.
Experimental: Cohort 3: LP-003 Dose 3 (Single)	Biological: LP-003 Dose 3 (Single); A single dose of LP-003 (Dose 3) was administered intravenously.
Experimental: Cohort 4: LP-003 Dose 4 (Single)	Biological: LP-003 Dose 4 (Single); A single dose of LP-003 (Dose 4) was administered intravenously.
Experimental: Cohort 5: LP-003 Dose 5 (Single)	Biological: LP-003 Dose 5 (Single); A single dose of LP-003 (Dose 5) was administered intravenously.
Placebo Comparator: Cohort 6: Placebo (Single)	Biological: Placebo (Single); A single dose of placebo was administered intravenously.
Experimental: Cohort 7: LP-003 Dose 6 (Multiple)	Biological: LP-003 Dose 6 (Multiple); LP-003 (Dose 6) was administered multiple times subcutaneously.
Experimental: Cohort 8: LP-003 Dose 7 (Multiple)	Biological: LP-003 Dose 7 (Multiple); LP-003 (Dose 7) was administered multiple times subcutaneously.
Experimental: Cohort 9: LP-003 Dose 8 (Multiple)	Biological: LP-003 Dose 8 (Multiple); LP-003 (Dose 8) was administered multiple times subcutaneously.
Placebo Comparator: Cohort 10: Placebo (Multiple)	Biological: Placebo (Multiple); Placebo was administered multiple times subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Number of subjects with treatment-related Treatment Emergent Adverse Events (TEAEs).	Observation for 280 days after administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to peak concentration (Tmax) of LP-003	The time when the blood drug concentration reaches its peak after a single dose of medication.	Observation for 280 days after administration
Maximum concentration (Cmax) of LP-003	The maximum concentration of LP-003 in the bloodstream after administration.	Observation for 280 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.	Observation for 280 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.	Observation for 280 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.	Observation for 280 days after administration
Assessment of immunogenicity	The proportion of anti drug antibody (ADA) positive subjects at different detection time points.	Observation for 280 days after administration
Assessment of total immunoglobulin E (IgE)	The changes in serum total immunoglobulin E (IgE) levels compared to baseline at different assessment time points.	Observation for 168 days after administration
Assessment of free IgE	The changes in serum free IgE levels compared to baseline at different assessment time points.	Observation for 168 days after administration

Collaborators and Investigators

• Sponsor: Longbio Pharma

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): September 3, 2023
• Study Completion (Estimated): March 15, 2024

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Actual): March 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Disease Attributes; Skin Diseases, Vascular; Hypersensitivity; Chronic Disease; Urticaria; Chronic Urticaria
• Other Study ID Numbers: P-10-LP003-2022-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No