A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants
NCT05483998 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2024-05-20
Summary
This phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TLC-2716 after single- and multiple-ascending doses in healthy subjects.
Conditions
- Healthy Subjects
Interventions
- DRUG
-
TLC-2716
TLC-2716
- OTHER
-
Placebo
Placebo to match
Sponsors & Collaborators
-
OrsoBio, Inc
lead INDUSTRY
Principal Investigators
-
OrsoBio Study Director · OrsoBio, Inc
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-09-09
- Primary Completion
- 2023-04-13
- Completion
- 2023-06-18
Countries
- New Zealand
Study Locations
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