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

Chronic Spontaneous Urticaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06294288
• Other study ID #: P-10-LP003-2022-01
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 1, 2021
• Est. completion date: March 15, 2024

Study information

• Verified date: February 2024
• Source: Longbio Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: March 15, 2024
• Est. primary completion date: September 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Spontaneous Urticaria
• Chronic Urticaria
• Urticaria

Intervention

Biological:
• LP-003 Dose 1 (Single)
A single dose of LP-003 (Dose 1) was administered intravenously.
• LP-003 Dose 2 (Single)
A single dose of LP-003 (Dose 2) was administered intravenously.
• LP-003 Dose 3 (Single)
A single dose of LP-003 (Dose 3) was administered intravenously.
• LP-003 Dose 4 (Single)
A single dose of LP-003 (Dose 4) was administered intravenously.
• LP-003 Dose 5 (Single)
A single dose of LP-003 (Dose 5) was administered intravenously.
• Placebo (Single)
A single dose of placebo was administered intravenously.
• LP-003 Dose 6 (Multiple)
LP-003 (Dose 6) was administered multiple times subcutaneously.
• LP-003 Dose 7 (Multiple)
LP-003 (Dose 7) was administered multiple times subcutaneously.
• LP-003 Dose 8 (Multiple)
LP-003 (Dose 8) was administered multiple times subcutaneously.
• Placebo (Multiple)
Placebo was administered multiple times subcutaneously.

Locations

Country	Name	City	State
China	Shanghai General Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Longbio Pharma

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Number of subjects with treatment-related Treatment Emergent Adverse Events (TEAEs).	Observation for 280 days after administration
Secondary	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
Secondary	Maximum concentration (Cmax) of LP-003	The maximum concentration of LP-003 in the bloodstream after administration.	Observation for 280 days after administration
Secondary	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
Secondary	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
Secondary	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
Secondary	Assessment of immunogenicity	The proportion of anti drug antibody (ADA) positive subjects at different detection time points.	Observation for 280 days after administration
Secondary	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
Secondary	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