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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Healthy males or females aged 18 through 50 years
- 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).
- 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.
- 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.
- The subjects fully understand the purpose, nature, method and possible adversereactions of the experiment, and voluntarily participate in the experiment and signthe informed consent.
- The subjects were able to communicate well with the researchers and complete the studyaccording to the protocol.
Exclusion
Exclusion Criteria:
- 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).
- Any history of Neisseria gonorrhea, meningitis infection, and Guillain-Barré syndrome.
- Contraindications to meningococcal vaccination (previous medical history such asepilepsy or other brain disorders).
- Presence or suspicion of active viral, bacterial, fungal, or parasitic infection,including herpes, shingles, or cold sores, within 14 days prior to screening.
- History of unexplained recurrent infections, or use of systemic antibiotics within 90days prior to dosing.
- Malignancy or history of malignancy, except non-melanoma skin cancer cured for morethan 3 years.
- Positive HIV test (HIV-Ab), positive hepatitis B virus (HBV) test (HBsAg), positivehepatitis C virus (HCV), positive anti-syphilis helix-specific antibodies.
- 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).
- Women who are pregnant, breastfeeding, or at risk of pregnancy.
- 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
ChinaActive - Recruiting
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