Safety, PK and PD of FLQ-101 in Premature Neonates

NCT ID: NCT07093255

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-12-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

FLQ-101

Group Type: EXPERIMENTAL

FLQ-101

Intervention Type: DRUG

The invervention comprises 3 Groups:

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

Interventions

FLQ-101

The invervention comprises 3 Groups:

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 4 Days
• Maximum Eligible Age: 5 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FELIQS INC.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Clinical Trial Office

Role: CONTACT

clinicaltrial@feliqs.com

+81-942-707-330

Other Identifiers

FLQCT-01

Identifier Type: -

Identifier Source: org_study_id