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drugset / Trial / NCT03000686

Study of GSK2586881 on Acute Hypoxia and Exercise

NCT03000686 ↗

Phase 1 Terminated 17 enrolled GlaxoSmithKline
RandomizedCrossoverTriple-blindTreatment

Summary

This study is conducted to examine how GSK2586881, a recombinant human ACE2 peptide, modulates the acute hypoxic pulmonary vasoconstriction (HPV) response in healthy volunteers. The study will be single-center, randomized, placebo-controlled and double blind (sponsor open). Subjects will be randomized to receive a single intravenous (IV) dose of GSK2586881 or placebo (saline) in a crossover design. The primary objective of the study is to evaluate the effect of a single IV dose of GSK2586881 on the HPV response in healthy volunteers during exercise under hypoxic conditions. Approximately 35 subjects will be enrolled for a maximum of 56 days.

Timeline

Start
2017-05-17
Primary completion
2019-01-04
Completion
2019-01-04

Outcome

Met primary endpoint

Stopped: “Study terminated for technical feasibility, operational considerations and futility in line with pre-specified criteria.”

release “In addition to meeting all primary endpoints regarding the safety and tolerability of APN01 via a new route of administration” invios.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject GSK2586881 Protein / enzyme biologic 0.8 mg/kg Intravenous

Indications

No indication recorded.