Conditions: Pre-eclampsia
Keywords: human recombinant RLX030 Pre-eclampsia hemodynamics Pharmacokinetics
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 3
Healthy volunteers: no

Brief summary:
This study is designed in two parts. Part 1 will assess the safety and tolerability of different doses of RLX030 when given to pregnant women with pre- eclampsia (elevated blood pressure with protein in urine). Part 2 will assess whether an optimal dose of RLX030 can prolong pregnancy in women with pre-eclampsia.

Detailed description:

Arms:
arm 1: In part 1, within each cohort, two (2) patients per cohort will be treated open label with RLX030 and two (2) patients will be treated double blind with RLX030 as intravenous infusion for 72 hours. There will be 3 cohorts in part 1 with different doses of RLX030.

In part 2, there is no open label treatment on RLX030. In part 2, patients will be randomized in a double-blind fashion to this arm with the optimal dose of RLX030 as intravenous infusion for 72 hours as determined from part 1. arm 2: In part 1, equal number of subjects will be treated with matching placebo of RLX030 as intravenous infusion for 72 hours in 3 cohorts.

In part 2, patients will be treated with matching placebo of RLX030 as intravenous infusion for 72 hours

Interventions: intervention 1: Placebo intervention 2: RLX030
Intervention descriptions: intervention 1: Placebo to RLX030 as intravenous infusion for 72 hours intervention 2: RLX030 1 mg/mL vials

Protocol document: