A Study to Evaluate SGB-3403 in Healthy Volunteers and Subjects With Elevated Low-Density Lipoprotein Cholesterol (LDL-C)

Phase 1

Not yet recruiting

• Conditions: Hyperlipidemias
• Interventions: Other: Placebo; Drug: SGB-3403; Other: Atorvastatin

• Registration Number: NCT06239714
• Lead Sponsor: Suzhou Sanegene Bio Inc.

Brief Summary

This study is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending doses (MAD) of SGB-3403 when single administered subcutaneously to healthy volunteers and multiple administered subcutaneously to subjects with elevated LDL-C to evaluate the safety, tolerance, PK, and PD.

Detailed Description

This study is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending doses (MAD) of SGB-3403 when single administered subcutaneously to healthy volunteers and multiple administered subcutaneously to subjects with elevated LDL-C. The study will be performed in 2 phases: SAD and MAD.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-25
• Last Update Submitted: 2024-01-25
• Study First Posted: 2024-02-02
• Last Update Posted: 2024-02-02
• Study Start: 2024-02-18
• Primary Completion: 2025-02-18
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo(Non-Statin MAD)	Placebo	-
SGB-3403(SAD)	SGB-3403	-
placebo(SAD)	Placebo	-
SGB-3403 and atorvastatin(statin MAD)	SGB-3403	-
SGB-3403 and atorvastatin(statin MAD)	Atorvastatin	-
placebo and atorvastatin(statin MAD)	Atorvastatin	-
placebo and atorvastatin(statin MAD)	Placebo	-
SGB-3403(Non-Statin MAD)	SGB-3403	-

Primary Outcome Measures

Name	Time	Method
Number of participants with abnormal laboratory tests results	169 days	To evaluate the safety and tolerability of SGB-3403 when administered subcutaneously in multiple-dose to subjects with elevated LDL-C
Number of participants with adverse events (AEs)	169 days	To evaluate the safety and tolerability of SGB-3403 when administered subcutaneously in multiple-dose to subjects with elevated LDL-C

Secondary Outcome Measures

Name	Time	Method
LDL-C change from baseline	265 days	To evaluate the pharmacodynamic effect of SGB-3403 on serum levels of LDL-C in subjects with elevated LDL-C
Maximum observed plasma concentration (Cmax)	48 hours	To characterize the pharmacokinetics of SGB-3403 in healthy volunteers and subjects with elevated LDL-C
Area under the concentration-time curve (AUC)	48 hours	To characterize the pharmacokinetics of SGB-3403 in healthy volunteers and subjects with elevated LDL-C
PCSK9 change from baseline	265 days	To evaluate the pharmacodynamic effect of SGB-3403 on plasma levels of proprotein convertase subtilisin/kexin type 9 in subjects with elevated LDL-C