Recruiting NCT07093255
Safety, PK and PD of FLQ-101 in Premature Neonates
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FLQ-101.
- Who it may be relevant to
- Registry conditions: Retinopathy of Prematurity (ROP). Basic parameters: 4 Days — 5 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
The purpose of this study is to evaluate safety and efficacy outcomes following exposure to FLQ-101.
Interventions
- Drug FLQ-101
The invervention comprises 3 Groups: * Group 1: Low Dose * Group 2: Middle Dose * Group 3: High Dose
Primary outcome measures
- Frequency of adverse events [Time frame: Day 1 to 36 weeks PMA(post menstrual age)]
Secondary outcome measures (2)
- Pharmacokinetic parameters of FLQ-101 [Time frame: Day 1 to 24 hours post first oral dose]
- Pharmacodynamic parameters of FLQ-101 [Time frame: Day 1 to 24 hours post first oral dose]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- St. David's Medical Center — Austin
Identifiers
NCT: NCT07093255 · FLQCT-01