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Purpose

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

Condition

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.