Safety, Tolerability, and PK/PD of CIGB-814 in Chinese Health Participants
Trial Parameters
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of CIGB-814 for injection after single and multiple administrations in healthy participants. Secondary objectives include the assessment of preliminary pharmacodynamics (PD) and immunogenicity. Exploratory objectives are to investigate changes in immune cell subsets and signaling pathways following multiple administrations of CIGB-814.
Eligibility Criteria
Inclusion Criteria: * Participants must meet all of the following criteria to be eligible for the study: 1. Healthy male or female participants aged 18 to 45 years, inclusive. 2. Male participants weighing at least 50.0 kg, and female participants weighing at least 45.0 kg, with a body mass index (BMI) between 19.0 and 26.0 kg/m², inclusive (BMI = weight \[kg\] / height² \[m²\]). 3. Able to communicate effectively with the investigators, understand and comply with all study requirements, and willing to adhere strictly to the study procedures and follow-up schedule. Participants must provide written informed consent prior to any study-related procedures. 4. From the date of signing the informed consent until 6 months after study completion, participants must not have plans for conception. Female participants must not have plans to donate oocytes and agree to use reliable contraception to avoid pregnancy. Male participants must not have plans to donate sperm and agree to use reliable con