A Study on Evaluating the Safety of HST101 in Healthy Chinese Participants
NCT Number: NCT06504043
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Hypercholesterolemia|Hyperlipidemias|Dyslipidemias|Lipid Metabolism Disorders|Metabolic Diseases
Interventions: DRUG: HST101
Sponsor: Hasten Biopharmaceutical Co., Ltd.
Collaborators: Medpace, Inc.|Wuxi Apptec Co.,Ltd.
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-01
Locations: West China Hospital of Sichuan University, Chengdu, Sichuan, 610044, China

Summary:
This is a single-center, randomized, double-blind, placebo-controlled, single SC dose cohort study to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of HST101 in Healthy Chinese Participants with Elevated LDL-C Levels.

Primary Outcome Measures: The primary objective of this study is to assess the safety and tolerability of a single SC dose of HST101 in Chinese healthy adult study participants with elevated LDL-C level(International Standard Unit: mmol/L), Safety and tolerability will be assessed by the incidence and severity of treatment emergent adverse events, 57 days
Secondary Outcome Measures: To assess the Cmax and dose proportionality of HST101 following a single SC dose, The Cmax and dose proportionality of HST101 will be measured at baseline and various time points over 57 days, 57 days|To assess the Tmax and dose proportionality of HST101 following a single SC dose, The Tmax and dose proportionality of HST101 will be measured at baseline and various time points over 57 days, 57 days|To assess the T1/2 and dose proportionality of HST101 following a single SC dose, The T1/2 and dose proportionality of HST101 will be measured at baseline and various time points over 57 days, 57 days|To assess the AUC0-t and dose proportionality of HST101 following a single SC dose, The AUC0-t and dose proportionality of HST101 will be measured at baseline and various time points over 57 days, 57 days|To assess the AUCinf and dose proportionality of HST101 following a single SC dose, The AUCinf and dose proportionality of HST101 will be measured at baseline and various time points over 57 days, 57 days|To assess the PD effect of a single SC dose of HST101 on serum unbound (free) PCSK9 concentrations and serum LDL-C concentrations, Serum free PCSK9 and LDL-C will be measured at baseline and various time points over 57 days, 57 days|To assess the effect of a single SC dose of HST101 on blood lipids including TC, HDL-C, VLDL-C, and TG, Serum TC,HDL-C,VLDL-C and TG（ISU:mmol/L）will be measured at baseline and various time points over 57 days to assess percent change from baseline over time, 57 days|To assess the effect of a single SC dose of HST101 on serum ApoB, Apo A1 concentrations, Serum Apo B(ISU:g/L) , Apo A1(ISU:g/L) concentrations will be measured at baseline and various time points over 57 days to assess percent change from baseline over time, 57 days|To assess the effect of a single SC dose of HST101 on serum Lp(a) concentrations, Serum Lp (a)(ISU: mg/L) concentrations will be measured at baseline and various time points over 57 days to assess percent change from baseline over time, 57 days|To assess the PK-PD relationship following a single SC dose of HST101, The PK-PD relationship will be measured over 57 days, 57 days|To assess immunogenicity (incidence, titer, and duration of ADAs/NAbs) following a single SC dose of HST101, Measurement of ADAs/NAbs will be done at baseline and various intervals after HST101 administration, 57 days