Dose Escalation of SNK-396 in Participants With Elevated Low-Density Lipoprotein Cholesterol
NCT05896969 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41
Last updated 2024-06-21
Summary
This is a Phase 1, multi-center, randomized, double-blinded, placebo-controlled single and multiple dose escalation study with SC doses of SNK-396 in participants with elevated LDL-C. The study will be divided into two parts:
* SAD cohorts
* MAD cohorts
Conditions
- Elevated Low-Density Lipoprotein Cholesterol
Interventions
- DRUG
-
SNK-396 - SAD cohort
A single dose of SNK-396 within the dose range of 25 to 800 mg, or matching placebo.
- DRUG
-
SNK-396 - MAD Cohort
Multiple doses of SNK-396 within the dose range of from 25 to 800 mg, or matching placebo.
Sponsors & Collaborators
-
SynerK Pharmatech (Suzhou) Limited
collaborator UNKNOWN - lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-04-27
- Primary Completion
- 2024-02-23
- Completion
- 2024-02-23
Countries
- Australia
Study Locations
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