Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06294288
Other study ID # P-10-LP003-2022-01
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT06077773 - Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria Phase 2
Completed NCT04538794 - A Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria Phase 1
Completed NCT01803763 - Prospective Double-blind Placebo-controlled Study of the Effect of Xolair (Omalizumab) in Chronic Urticaria Patients Phase 2/Phase 3
Recruiting NCT05298215 - A Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Efficacy of UB-221 IV Infusion as an add-on Therapy in Patients With Chronic Spontaneous Urticaria Phase 2
Terminated NCT04612725 - A Study to Investigate the Use of Benralizumab in Patients With Chronic Spontaneous Urticaria Who Are Symptomatic Despite the Use of Antihistamines (ARROYO) Phase 2
Terminated NCT05528861 - A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria Phase 2
Completed NCT04109313 - An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU Phase 2
Completed NCT03580356 - A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines. Phase 3
Completed NCT03580369 - A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines Phase 3
Completed NCT05030311 - A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines Phase 3
Recruiting NCT06162728 - Dose Escalation Trial Of Safety, Pharmacokinetic/Pharmacodynamic And Preliminary Clinical Activity of Briquilimab In Adult Patients With Chronic Spontaneous Urticaria (CSU) Phase 1/Phase 2
Completed NCT05107115 - Rilzabrutinib for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine Phase 2
Recruiting NCT06042478 - A Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo and With Omalizumab as Active Control in CSU Adult Patients. Phase 3
Terminated NCT04159701 - A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria Phase 2
Completed NCT03749135 - Dupilumab in Chronic Spontaneous Urticaria Phase 2
Not yet recruiting NCT06396026 - A Study of Efficacy and Safety of TLL-018 in CSU Participants Phase 3
Completed NCT02649218 - A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients Phase 2
Active, not recruiting NCT05368285 - A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria Phase 2
Completed NCT05373355 - Safety and Efficacy of TLL018 in Patients With Chronic Spontaneous Urticaria. Phase 1
Not yet recruiting NCT06365879 - To Compare Efficacy and Safety of CMAB007 and Xolair® in Patients With Chronic Spontaneous Urticaria Phase 3