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NCT03177603 · ClinicalTrials.gov registry record · Phase 2
A Dose-escalation Study in Subjects With Pulmonary Arterial Hypertension (PAH)
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT03177603 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 23 participants.
The verdict
NCT03177603, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study 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.
Interventions
- DRUG GSK2586881
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2018-02-21 |
| Est. Completion | 2019-05-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03177603
The ClinicalTrials.gov registry entry for NCT03177603 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which GSK2586881 is the first listed.
NCT03177603 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03177603 about?
NCT03177603 is a clinical study titled "A Dose-escalation Study in Subjects With Pulmonary Arterial Hypertension (PAH)". 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...
What is the current status of trial NCT03177603?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2018-02-21. Estimated completion is 2019-05-07.
What interventions are being tested in trial NCT03177603?
The interventions under investigation include: GSK2586881 (DRUG).
Who is sponsoring clinical trial NCT03177603?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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