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

NCT07093255 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-04-21

No results posted yet for this study

Summary

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

Conditions

  • Retinopathy of Prematurity (ROP)

Interventions

DRUG

FLQ-101

The invervention comprises 3 Groups: * Group 1: Low Dose * Group 2: Middle Dose * Group 3: High Dose

Sponsors & Collaborators

  • FELIQS INC.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Days
Max Age
5 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-03
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07093255 on ClinicalTrials.gov