A Study of Single and Multiple Doses of LP-005 in Healthy Adult Participants

Last updated: February 27, 2024
Sponsor: Longbio Pharma
Overall Status: Active - Recruiting

Phase

1

Condition

Anemia

Proteinuria

Hemoglobinuria, Paroxysmal

Treatment

Placebo (Single)

LP-005 Dose 7 (Multiple)

LP-005 Dose 6 (Single)

Clinical Study ID

NCT06294301
P10-LP005-01
  • 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-005 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-005 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 with a weight of ≥50 kg, female subjects with a weight of ≥45 kg, andBMI between 19.0 and 26.0 kg/m² (inclusive).
  3. Vaccination: Meningococcal Conjugate Vaccine, Serogroups A, C, W, Y (MPV-ACYW)meningococcal conjugate vaccine and Streptococcus pneumoniae vaccine should be given 14 days or more before randomisation.
  4. 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.
  5. The subjects fully understand the purpose, nature, method and possible adversereactions of the experiment, and voluntarily participate in the experiment and signthe informed consent.
  6. The subjects were able to communicate well with the researchers and complete the studyaccording to the protocol.

Exclusion

Exclusion Criteria:

  1. Participants who are immunocompromised or have one of the following underlyingdiseases: anatomic absence of spleen (including sickle cell disease); congenitalcomplement component deficiencies (complement component 3 and complement component 4).
  2. Any history of Neisseria gonorrhea, meningitis infection, and Guillain-Barré syndrome.
  3. Contraindications to meningococcal vaccination (previous medical history such asepilepsy or other brain disorders).
  4. Presence or suspicion of active viral, bacterial, fungal, or parasitic infection,including herpes, shingles, or cold sores, within 14 days prior to screening.
  5. History of unexplained recurrent infections, or use of systemic antibiotics within 90days prior to dosing.
  6. Malignancy or history of malignancy, except non-melanoma skin cancer cured for morethan 3 years.
  7. Positive HIV test (HIV-Ab), positive hepatitis B virus (HBV) test (HBsAg), positivehepatitis C virus (HCV), positive anti-syphilis helix-specific antibodies.
  8. Participation in a clinical trial of any other drug within 3 months prior to screeningor within 5 half-lives of other clinical trial drugs (selecting the longer timeperiod).
  9. Women who are pregnant, breastfeeding, or at risk of pregnancy.
  10. Any condition deemed unsuitable for study participation by the investigator.

Study Design

Total Participants: 78
Treatment Group(s): 11
Primary Treatment: Placebo (Single)
Phase: 1
Study Start date:
November 19, 2023
Estimated Completion Date:
October 30, 2024

Connect with a study center

  • Shanghai Public Health Clinical Center

    Shanghai, Shanghai
    China

    Active - Recruiting

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