Recombinant Surfactant Protein D (rfhSP-D) to Prevent Neonatal Chronic Lung Disease — RESPONSE  

Bronchopulmonary Dysplasia Clinical Trial

Official title: Phase 1 Safety Trial of Recombinant Surfactant Protein D to Prevent Neonatal Chronic Lung Disease

Status Not yet recruiting

Clinical Trial Summary

The purpose of this study is to identify the safest dose of recombinant surfactant protein D (drug name: rfhSP-D) that can be administered to preterm infants born at less than 28 weeks gestation, and to help identify whether this can prevent the development of neonatal chronic lung disease.

Clinical Trial Description

This is a Phase I, dose escalation safety study that aims to identify the recommended phase 2 dose of recombinant fragment of human surfactant protein D (rfhSP-D) (drug name: rfhSP-D) for infants at risk of neonatal chronic lung disease. This study will aim to establish if the administration of rfhSP-D to the lungs of preterm babies, via an endotracheal tube, is safe at the proposed dosage range (1mg/kg - 4mg/kg) and whether this dose results in detectable concentrations in lung secretions or serum.

Surfactant protein D (SP-D) is a naturally occurring component of the surfactant system with anti-inflammatory properties. Current surfactant replacement therapy contains phospholipids and surfactant proteins B and C (SP-B and SP-C) but no surfactant protein A (SP-A) or surfactant protein D (SP-D).

Proof of concept regarding the anti-infective and anti-inflammatory activity of SP-D has been achieved in mouse and a preterm lamb models of lung disease and supports increasing evidence of the role played by deficiency of SP-D in human respiratory diseases.

Subjects will be enrolled in cohorts with increasing dose. Whether or not the dose is escalated will depend on the occurrence of dose limiting events (DLE) in all current patients and the doses that they have received. A model will be used to estimate the risk of DLE per dose level. Initial estimates of these risks will be updated using data collected throughout the trial.

Up to 24 infants of less than 28 weeks gestation will be recruited in the study and receive intra-tracheal administration of SP-D59, in the dose range 1mg/kg, 2mg/kg or 4mg/kg per dose for up to 3 doses. The first dose of SP-D59 will be given as soon as possible (within 2 hours) after the first dose of standard surfactant therapy (e.g., Curosurf). Subsequent doses of the IMP will be given at 12 hours and 24 hours after the first dose was administered. ;

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Chronic Lung Disease of Prematurity
• Lung Diseases
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome in Premature Infant
• Respiratory Distress Syndrome, Newborn

• NCT number: NCT05898633
• Study type: Interventional
• Source: University College, London
• Contact: Trial Manager
• Phone: 020 3108 4255
• Email: cctu.response@ucl.ac.uk
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: December 2023
• Completion date: December 2024