NCT07093255

Safety, PK and PD of FLQ-101 in Premature Neonates

A Phase 1b, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of FLQ-101 in Premature Neonates at High Risk of Developing ROP

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: FELIQS INC. · Industry
• Sex: All
• Age: 4 Days – 5 Days
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate safety and efficacy outcomes following exposure to FLQ-101.

Conditions

• Retinopathy of Prematurity (ROP)

Interventions

Type	Name	Description
DRUG	FLQ-101	The invervention comprises 3 Groups: * Group 1: Low Dose * Group 2: Middle Dose * Group 3: High Dose

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-07-30
• Last updated: 2025-07-30

Regulatory

• FDA-regulated drug study