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

Phase 1 Completed 18 enrolled University College, London Medical Research Council · collab

NaSingle-groupOpen-labelTreatment

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 30 weeks gestation, and to help identify whether this can prevent the development of neonatal chronic lung disease.

Timeline

Start: 2024-04-06
Primary completion: 2025-12-05
Completion: 2025-12-31

Publications

Bhatt R, Madsen J, Castillo-Hernandez T, Chant K, Dehbi HM, Marlow N, Clark H. Recombinant fragment of human surfactant protein D to prevent neonatal chronic lung disease (RESPONSE): a protocol for a phase I safety trial in a tertiary neonatal unit. BMJ Open. 2024 Aug 17;14(8):e086394. doi: 10.1136/bmjopen-2024-086394.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Recombinant fragment of human surfactant protein D	Protein / enzyme biologic	1 mg/kg	Other
Subject	Recombinant fragment of human surfactant protein D	Protein / enzyme biologic	2 mg/kg	Other
Subject	Recombinant fragment of human surfactant protein D	Protein / enzyme biologic	4 mg/kg	Other

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

Summary

Timeline

Publications

Drugs

Indications