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

Last updated: February 27, 2024
Sponsor: Longbio Pharma
Overall Status: Active - Not Recruiting

Phase

1

Condition

Urticaria

Hives (Urticaria)

Treatment

LP-003 Dose 7 (Multiple)

Placebo (Multiple)

Placebo (Single)

Clinical Study ID

NCT06294288
P-10-LP003-2022-01
  • Ages 18-50
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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 BMIbetween 19.0 and 28.0 kg/m² (inclusive).
  3. Male subjects and their partners or female subjects must agree to use one or morenon-pharmaceutical contraceptive methods (such as total abstinence, condoms, Iuds,partner ligation, etc.) during the trial period and for 6 months after the trial, anddo not plan to donate sperm or eggs.
  4. The subjects fully understand the purpose, nature, method and possible adversereactions of the experiment, and voluntarily participate in the experiment and signthe informed consent.
  5. The subjects were able to communicate well with the researchers and complete the studyaccording to the protocol.

Exclusion

Exclusion Criteria:

  1. People who are allergic to the experimental drug and any of its excipients, have ahistory of allergy to monoclonal antibodies, and are allergic to multiple drugs andfood.
  2. Patients who have been or are currently suffering from any clinically serious diseasessuch as circulatory system, endocrine system, nervous system, digestive system,respiratory system, urogenital system, hematology, immunology, psychiatric andmetabolic abnormalities, or any other diseases that can interfere with the testresults.
  3. Patients who had undergone surgery within 3 months before the trial that theresearchers judged would affect drug absorption, distribution, metabolism, andexcretion, or had surgery within 4 weeks prior to the trial, or planned to havesurgery 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 areawithin 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 immunodeficiencyvirus antibodies, treponema pallidum antibodies A positive person.
  8. Patients who have received any biological agent (including antibodies or derivativessuch 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 toscreening.
  10. The investigator deems any condition unsuitable for study participation.

Study Design

Total Participants: 70
Treatment Group(s): 10
Primary Treatment: LP-003 Dose 7 (Multiple)
Phase: 1
Study Start date:
July 01, 2021
Estimated Completion Date:
March 15, 2024

Connect with a study center

  • Shanghai General Hospital

    Shanghai, Shanghai
    China

    Site Not Available

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