Retinopathy of Prematurity (ROP)Phase 1tROPhy-1NCT07093255
Safety, PK and PD of FLQ-101 in Premature Neonates
A Phase 1 study testing FLQ-101 in people with Retinopathy of Prematurity (ROP), run by FELIQS INC. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate safety and efficacy outcomes following exposure to FLQ-101. Read more about this study
- Who is it for?
- Ages 4 to 5 days
- Conditions the study is for
- Retinopathy of Prematurity (ROP)
- What is being tested?
- FLQ-101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2026to 31 Dec 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 5 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Written consent is obtained from parent(s) or legal guardian.
- Neonates born at 25 weeks +0 days and 27 weeks +6 days of gestation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. David's Medical Center
Austin, Texas, 78705
Clininical Research Cordinator, 512-544-8070
About this study
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
The purpose of this study is to evaluate safety and efficacy outcomes following exposure to FLQ-101.
- Conditions
- Retinopathy of Prematurity (ROP)
- Being tested
- FLQ-101
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLQ-101Drug
The invervention comprises 3 Groups:
- Group 1: Low Dose
- Group 2: Middle Dose
- Group 3: High Dose
| Study group | Role | What they receive |
|---|---|---|
| FLQ-101 | Experimental | Not described Receives: Drug: FLQ-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events
Measured: Day 1 to 36 weeks PMA(post menstrual age)
Secondary outcomes (2)
Pharmacokinetic parameters of FLQ-101
Measured: Day 1 to 24 hours post first oral dose
Pharmacodynamic parameters of FLQ-101
Measured: Day 1 to 24 hours post first oral dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start3 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of Prematurity (ROP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FELIQS INC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093255
- Sponsor's protocol ID
- FLQCT-01
- Acronym
- tROPhy-1
- Status last verified
- Oct 2026
- First submitted
- 16 Jul 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided