A Phase I, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PBGENE-HBV in Patients with Chronic Hepatitis B

The primary objective of this first-in-human study is to evaluate the safety and tolerability of PBGENE-HBV in individuals diagnosed with chronic hepatitis B through the administration of escalating doses. This investigation is clinically significant for establishing the initial safety profile of the investigational product. Secondary objectives include the assessment of efficacy and the evaluation of the pharmacokinetic properties of the drug within the human physiological system.

The study involves a total of 22 patients. The population includes both males and females within the specified age range. All participants are diagnosed with chronic hepatitis B. The sponsor did not provide additional information regarding lifestyle considerations or specific selection methodologies.

This Phase 1, first-in-human clinical trial is designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics of PBGENE-HBV in individuals diagnosed with chronic hepatitis B. The study utilizes an escalating dose methodology to assess the biological response and safety profile of the investigational product. The clinical procedure begins with a screening visit to determine eligibility. Following administration, participants will undergo scheduled follow-up visits to monitor physiological responses and safety parameters. The protocol concludes with an end-of-study visit. Total participant involvement is determined by the established visit schedule. Early termination from the study may occur based on predefined clinical safety criteria.

The assessment of efficacy in this clinical trial for Chronic Hepatitis B is not specified.