Relative Bioavailability Study of CX2101A for the Treatment of COVID-19
NCT06864182 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-03-14
Summary
The study comprises three parts: single ascending dose (SAD) studies of CX2101A tablets at 40 mg, 100 mg, and 160 mg; a relative bioavailability (BA) study comparing single-dose administration of 100 mg CX2101A tablets and enteric-coated tablets; and a multiple ascending dose (MAD) study of CX2101A tablets. The BA study (100 mg) is integrated into the SAD study(Nested within the SAD protocol to optimize resource utilization).
Conditions
- COVID-19
- Coronavirus Infection
Interventions
- DRUG
-
CX2101A tablet
CX2101A tablet
- DRUG
-
CX2101A placebo tablet
CX2101A placebo tablet
- DRUG
-
CX2101A enteric-coated tablet
CX2101A enteric-coated tablet
- DRUG
-
CX2101A placebo enteric-coated tablet
CX2101A placebo enteric-coated tablet
Sponsors & Collaborators
-
Heronova Pharmaceuticals
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-03-21
- Primary Completion
- 2024-05-25
- Completion
- 2024-05-25
Countries
- China
Study Locations
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