Trials / Completed
CompletedNCT04707131
A Study of Single Ascending Dose of LEM-S401 in Healthy Participants
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase I Clinical Trial to Evaluate the Characteristics of the Safety, Tolerability and Pharmacokinetics of LEM-S401 in Healthy Adult Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Lemonex Inc. · Industry
- Sex
- All
- Age
- 19 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
The primary objective of the study is to assess the safety and tolerability of single dose of LEM-S401 in healthy adult subjects.
Detailed description
This study is designed to evaluate the safety and tolerability of LEM-S401 administered as subcutaneous injection in healthy adult subjects. Overall, 18 subjects will be studied in 3 groups. Each subject will receive LEM-S401 or placebo subcutaneously.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LEM-S401 | siRNA encapsulated in DegradaBALL® |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2022-07-11
- Primary completion
- 2022-10-18
- Completion
- 2023-02-03
- First posted
- 2021-01-13
- Last updated
- 2023-02-16
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04707131. Inclusion in this directory is not an endorsement.