A Safety, Tolerability, and Efficacy Study of IBI314 in Ambulatory Patients With COVID-19
NCT05162365 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 248
Last updated 2023-12-18
Summary
This is a dose-finding, inferentially seamless Phase 1/2 study evaluating the safety, tolerability and efficacy of IBI314 in Ambulatory Patients with COVID-19.
Conditions
Interventions
- BIOLOGICAL
-
IBI314
Low/medium/high dose, intravenously, once, on Day 1
- OTHER
-
Placebo
Placebo, intravenously, once, on Day 1
Sponsors & Collaborators
-
Innovent Biologics (Suzhou) Co. Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-06
- Primary Completion
- 2022-06-29
- Completion
- 2022-11-18
- FDA Drug
- Yes
Countries
- United States
Study Locations
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