A Phase 1, Randomized, Double-Blind, Placebo-Controlled, SAD and MAD Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered SGB-3403 in Healthy Volunteers and Subjects With Elevated LDL-C
Overview
- Phase
- Phase 1
- Intervention
- SGB-3403
- Conditions
- Hyperlipidemias
- Sponsor
- Suzhou Sanegene Bio Inc.
- Enrollment
- 64
- Primary Endpoint
- Number of participants with abnormal laboratory tests results
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
SGB-3403(SAD)
Intervention: SGB-3403
placebo(SAD)
Intervention: Placebo
SGB-3403(Non-Statin MAD)
Intervention: SGB-3403
placebo(Non-Statin MAD)
Intervention: Placebo
SGB-3403 and atorvastatin(statin MAD)
Intervention: SGB-3403
SGB-3403 and atorvastatin(statin MAD)
Intervention: Atorvastatin
placebo and atorvastatin(statin MAD)
Intervention: Atorvastatin
placebo and atorvastatin(statin MAD)
Intervention: Placebo
Outcomes
Primary Outcomes
Number of participants with abnormal laboratory tests results
Time Frame: 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)
Time Frame: 169 days
To evaluate the safety and tolerability of SGB-3403 when administered subcutaneously in multiple-dose to subjects with elevated LDL-C
Secondary Outcomes
- LDL-C change from baseline(265 days)
- Maximum observed plasma concentration (Cmax)(48 hours)
- Area under the concentration-time curve (AUC)(48 hours)
- PCSK9 change from baseline(265 days)