Safety, Tolerability, and PK/PD of CIGB-814 in Chinese Health Participants
A Phase I Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Pharmacodynamics of Single and Multiple Doses of CIGB-814 in Healthy Participants
Yi Fang
70 participants
Aug 18, 2025
INTERVENTIONAL
Conditions
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
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
CIGB-814, single ascending dose, SC injection
CIGB-814 placebo, single ascending dose, SC injection
CIGB-814, multiple ascending dose, SC injection
CIGB-814 placebo, multiple ascending dose, SC injection
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07182656