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

Korábbi kezelés

• Contraindications to meningococcal vaccination (previous medical history such as epilepsy 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 90 days prior to dosing.
• Participation in a clinical trial of any other drug within 3 months prior to screening or within 5 half-lives of other clinical trial drugs (selecting the longer time period).

Más betegség

• Participants who are immunocompromised or have one of the following underlying diseases: anatomic absence of spleen (including sickle cell disease); congenital complement component deficiencies (complement component 3 and complement component 4).
• Any history of Neisseria gonorrhea, meningitis infection, and Guillain-Barré syndrome.
• Malignancy or history of malignancy, except non-melanoma skin cancer cured for more than 3 years.
• Positive HIV test (HIV-Ab), positive hepatitis B virus (HBV) test (HBsAg), positive hepatitis C virus (HCV), positive anti-syphilis helix-specific antibodies.
• Any condition deemed unsuitable for study participation by the investigator.

Egyéb

• Women who are pregnant, breastfeeding, or at risk of pregnancy.

• 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, and BMI 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 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.
• 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.
• The subjects were able to communicate well with the researchers and complete the study according to the protocol.