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

Part of paid clinical trials in Austin, Texas.

Sponsor
FELIQS INC.
Study ID
NCT07093255
Phase
PHASE1
Status
Recruiting

Conditions

  • Retinopathy of Prematurity (ROP)

Eligibility Criteria

Sex
ALL
Age
4 Days - 5 Days
Healthy Volunteers
Not accepted

Interventions

  • FLQ-101 — DRUG
    The invervention comprises 3 Groups: * Group 1: Low Dose * Group 2: Middle Dose * Group 3: High Dose

Study Details

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

Key Dates

Start date
Apr 3, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: FLQ-101

Primary Outcome Measure

Frequency of adverse events [ Time Frame: Day 1 to 36 weeks PMA(post menstrual age) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. David's Medical CenterAustinTexas78705
Clininical Research Cordinator
512-544-8070

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