CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 49 enrolled
Drug / intervention
Ravulizumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05396742
NCT05396742Phase 1Completed

A Partially Randomized, Sequential Cohort, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Subcutaneous Ravulizumab Coadministered With rHuPH20 in Healthy Adult Volunteers

Alexion Pharmaceuticals, Inc.·interventional·Posted May 31, 2022·Updated Jan 22, 2024

In Brief

A Phase 1 clinical trial evaluating Ravulizumab and rHuPH20 for Healthy. Completed, enrolled 49 participants across 1 site.

Detailed Summary

The main objectives of this study were to estimate the absolute bioavailability of ravulizumab/rHuPH20 subcutaneous (SC) and to assess the safety and tolerability of ravulizumab/rHuPH20 SC.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedMay 31, 2022
Enrollment StartAug 9, 2018
Primary CompletionMay 21, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 4.1 years ago

Interventions

Ravulizumabdrug

Solution for infusion or injection, as applicable

rHuPH20drug

Solution for infusion