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
FELIQS INC.
Summary
The purpose of this study is to evaluate safety and efficacy outcomes following exposure to FLQ-101.
Eligibility
- Age range
- 0–0 years
- Sex
- All
- 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 hea…
Interventions
- DrugFLQ-101
The invervention comprises 3 Groups: * Group 1: Low Dose * Group 2: Middle Dose * Group 3: High Dose
Location
- St. David's Medical CenterAustin, Texas