A Dose-escalation Study in Subjects With Pulmonary Arterial Hypertension (PAH)
Summary
GSK2586881, a purified intravenous (IV) formulation of soluble recombinant human Angiotensin Converting Enzyme (rhACE2) is being investigated as a treatment for PAH. This GlaxoSmithKline (GSK) study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK2586881 in subjects with PAH. This open-label, dose-escalation study will comprise of 4 separate groups based on the planned dose range, and subjects in each group will be administered a single dose of GSK2586881 ranging between 0.1, 0.2, 0.4 and 0.8 milligram per kilogram (mg/kg) via IV route. Dose escalation will occur after 4 subjects have been dosed per cohort and review of safety, tolerability, PK and hemodynamic data up to 24 hours post dose has taken place. A maximum of 27 subjects will be included in the study and the total duration of the study will be up to a maximum of 59 days.
Timeline
- Start
- 2018-02-21
- Primary completion
- 2019-05-07
- Completion
- 2019-05-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GSK2586881 | Protein / enzyme biologic | 0.1 mg/kg | Intravenous |
| Subject | GSK2586881 | Protein / enzyme biologic | 0.2 mg/kg | Intravenous |
| Subject | GSK2586881 | Protein / enzyme biologic | 0.4 mg/kg | Intravenous |
| Subject | GSK2586881 | Protein / enzyme biologic | 0.8 mg/kg | Intravenous |