At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 159 enrolled
Drug / intervention
SHR-1209drug
Likely dose
SHR-1209 450mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-center, Randomized, Parallel, Open-label Study to Compare the Bioavailability, Pharmacodynamics, and Safety of SHR-1209 Given as Single Subcutaneous Injection at Different Sites in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating SHR-1209 for Hypercholesterolemia and Hyperlipidemia. Completed, enrolled 159 participants across 1 site.
Detailed Summary
In order to meet the preferences and needs of different patients for injection sites and improve the medication compliance of patients, it is planned to compare the bioavailability, pharmacokinetics, pharmacodynamic and safety data to assess feasibility of multiple injection sites for administration.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia and Hyperlipidemia
CountriesChina
Collaborators--
Timeline
Phase 1CompletedFinished
2023202420252026
First PostedMay 2022
Enrollment StartMay 2022
Primary CompletionDec 2022
TodayJul 2026
First PostedMay 12, 2022
Enrollment StartMay 25, 2022
Primary CompletionDec 31, 2022
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 4.1 years ago
Interventions
SHR-1209drug
SHR-1209，single subcutaneous injection of 450mg