NCT06864182

Relative Bioavailability Study of CX2101A for the Treatment of COVID-19

A Study to Evaluate the Relative Bioavailability of Single-Dose CX2101A Tablets and Enteric-Coated Tablets, and the Pharmacokinetics of Single and Multiple Doses of CX2101A Tablets in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Heronova Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Detailed description

1. Randomized, Double-Blind, Placebo-Controlled Design All studies are conducted under standardized fasting conditions to eliminate food interference Blinding is maintained throughout the entire study period for both subjects and investigators 2. Single Ascending Dose (SAD) Study Dose Groups: 40 mg, 100 mg, 160 mg (3 cohorts) Subject Allocation: 10 subjects/cohort (8 CX2101A + 2 placebo) Integration with BA Study: The 100 mg cohort will serve as the reference for bioavailability evaluation Subjects completing SAD phase will proceed to receive enteric-coated formulations 3. Multiple Ascending Dose (MAD) Study Dose Groups: Same 40 mg, 100 mg, 160 mg cohorts Subject Allocation: 10 subjects/cohort (8 CX2101A + 2 placebo) Administration Schedule: Daily dosing for 5 consecutive days Relative Bioavailability (BA) Study 4. Cohort Integration: Conducted within the 100 mg SAD group (N=10) Treatment Sequence: Initial single-dose administration of CX2101A tablets ≥7-day washout period (PK data-driven adjustment) Second single-dose administration of enteric-coated tablets Subject Allocation: CX2101A tablets group: 8 subjects (CX2101A + 8 placebo) Enteric-coated group: 8 subjects (CX2101A + 8 placebo)

Conditions

• COVID-19
• Coronavirus Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-03-21
• Primary completion: 2024-05-25
• Completion: 2024-05-25
• First posted: 2025-03-07
• Last updated: 2025-03-14

Locations

1 site across 1 country: China