The Comprehensive Clinical Trials Unit at UCL



Phase 1 safety study of Recombinant Surfactant Protein D to prevent neonatal Chronic Lung Disease (nCLD) in preterm infants

21 May 2020

Chronic Lung Disease (CLD) is a serious, long-term lung condition that can affect up to 70% of babies born prematurely before 28 weeks of pregnancy.

Surfactant protein D is a naturally occurring protein which may be able to protect against the development of CLD. Studies in lambs, mice and humans have shown that surfactant protein D plays an important role as an anti-inflammatory protein and in helping to fight infection, both of which are known to have a role in development of CLD.

We are now able to manufacture a version of surfactant protein D, recombinant surfactant protein D, that is a part of the naturally occurring version. The purpose of RESPONSE, a Phase 1 first-in-human clinical trial, is to look at what the safest dose of surfactant protein D is and how it helps to prevent CLD in these high-risk babies. The goal of the study is to find the recommended dose (low, medium or high) for premature babies while keeping them safe. This recommended dose can then be tested in a Phase 2 trial.

Aim: To find the recommended dose of recombinant surfactant protein D for a Phase 2 trial.
Population: Preterm infants born at between 23 weeks and 0 days and <28 weeks and 0 days gestation.
Recruitment target: 24
Trial status: In set-up, Clinical Trial Application submission planned for 2021
Funder: Medical Research Council
Sponsor: University College London