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

Purpose

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

Condition

  • Retinopathy of Prematurity (ROP)

Eligibility

Eligible Ages
Between 4 Days and 5 Days
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Written consent is obtained from parent(s) or legal guardian. - Neonates born at 26 weeks +0 days and 27 weeks +6 days of gestation. - Male or female infants with a birth weight greater than or equal to 650 gm.

Exclusion Criteria

  • Neonates with congenital malformation of the eye or any other ocular condition that may prevent or relevantly affect any of the assessments or procedures. - Neonates with serious congenital anomalies, severe congenital infection, and chromosomal abnormalities. - Neonates who are seriously ill and not expected to survive. - Neonates with heart disease, including cardiomyopathy, serious arrhythmias, and congenital heart disease. (Neonates with patent foramen ovale may be included in the study if clinically stable). - Neonates that are small for gestational age defined as having a weight <10th percentile at birth based on the Fenton growth charts for gestational age and sex. - Neonates with history of or ongoing intraventricular hemorrhage (IVH) grades 2, 3 or 4. Neonates with IVH grade 1 may be included in the study at the discretion of the PI. - Neonates with any other medical conditions or clinically significant comorbidities or circumstances that in the opinion of the investigator may have a relevant impact on study participation or any of the study assessments or procedures. - Infants scheduled to participate in other interventional clinical trials while participating in the study and until reaching end of study.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
FLQ-101
  • Drug: FLQ-101
    The invervention comprises 3 Groups: - Group 1: Low Dose - Group 2: Middle Dose - Group 3: High Dose

Recruiting Locations

St. David's Medical Center
Austin, Texas 78705
Contact:
Clininical Research Cordinator
512-544-8070

More Details

Status
Recruiting
Sponsor
FELIQS INC.

Study Contact

Clinical Trial Office
+81-942-707-330
clinicaltrial@feliqs.com