Safety, PK and PD of FLQ-101 in Premature Neonates
tROPhy-1
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
1 other identifier
interventional
18
1 country
1
Brief Summary
The purpose of this study is to evaluate safety and efficacy outcomes following exposure to FLQ-101.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2025
CompletedFirst Posted
Study publicly available on registry
July 30, 2025
CompletedStudy Start
First participant enrolled
April 3, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
April 21, 2026
April 1, 2026
9 months
July 16, 2025
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency of adverse events
Day 1 to 36 weeks PMA(post menstrual age)
Secondary Outcomes (2)
Pharmacokinetic parameters of FLQ-101
Day 1 to 24 hours post first oral dose
Pharmacodynamic parameters of FLQ-101
Day 1 to 24 hours post first oral dose
Study Arms (1)
FLQ-101
EXPERIMENTALInterventions
The invervention comprises 3 Groups: * Group 1: Low Dose * Group 2: Middle Dose * Group 3: High Dose
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- FELIQS INC.lead
Study Sites (1)
St. David's Medical Center
Austin, Texas, 78705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2025
First Posted
July 30, 2025
Study Start
April 3, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
April 21, 2026
Record last verified: 2026-04