NCT07093255 Safety, PK and PD of FLQ-101 in Premature Neonates
| NCT ID | NCT07093255 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | FELIQS INC. |
| Condition | Retinopathy of Prematurity (ROP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2026-04-03 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2026-04-03 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate safety and efficacy outcomes following exposure to FLQ-101.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07093255 clinical trial?
This trial is open to participants of all sexes, aged 4 Days or older, up to 5 Days, studying Retinopathy of Prematurity (ROP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07093255 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07093255 currently recruiting?
Yes, NCT07093255 is actively recruiting participants. Contact the research team at clinicaltrial@feliqs.com for enrollment information.
Where is the NCT07093255 trial being conducted?
This trial is being conducted at Austin, United States.
Who is sponsoring the NCT07093255 clinical trial?
NCT07093255 is sponsored by FELIQS INC.. The trial plans to enroll 18 participants.