Recruiting
Phase 1

FLQ-101

Sponsor:

FELIQS INC.

Code:

NCT07093255

Conditions

Retinopathy of Prematurity (ROP)

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

FLQ-101

Study Details

Brief summary:

The purpose of this study is to evaluate safety and efficacy outcomes following exposure to FLQ-101.

Conditions

Retinopathy of Prematurity (ROP)

Study ID

NCT07093255

Start date

Apr 3, 2026

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

18 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: FLQ-101

Interventions

FLQ-101

The invervention comprises 3 Groups:

  • Group 1: Low Dose
  • Group 2: Middle Dose
  • Group 3: High Dose

Primary outcome measure

  • Frequency of adverse events [ Time Frame: Day 1 to 36 weeks PMA(post menstrual age) ]

Central Contacts and Locations

Central contacts

Clinical Trial Office

+81-942-707-330clinicaltrial@feliqs.com

Locations

St. David's Medical Center

Recruiting

Austin, Texas, United States, 78705

Contacts

Clininical Research Cordinator

512-544-8070

More Information

Sponsor

FELIQS INC.

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by FELIQS INC. on 2026-04-21.