Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05898633
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-30
First Post:
2023-03-24
Brief Title:
Recombinant Surfactant Protein D rfhSP-D to Prevent Neonatal Chronic Lung Disease
Sponsor:
University College London
Organization:
University College London
Study Overview
Official Title:
Phase 1 Safety Trial of Recombinant Surfactant Protein D to Prevent Neonatal Chronic Lung Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESPONSE
Brief 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
Detailed 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 1mgkg - 4mgkg 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 1mgkg 2mgkg or 4mgkg 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 eg Curosurf Subsequent doses of the IMP will be given at 12 hours and 24 hours after the first dose was administered
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 1mgkg 2mgkg or 4mgkg 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 eg Curosurf Subsequent doses of the IMP will be given at 12 hours and 24 hours after the first dose was administered
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None