Trials / Completed
CompletedNCT05396742
Pharmacokinetic Study of Ravulizumab Administered Subcutaneously With Recombinant Human Hyaluronidase PH20 (rHuPH20) in Healthy Adult Volunteers
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ravulizumab | Solution for infusion or injection, as applicable |
| DRUG | rHuPH20 | Solution for infusion |
Timeline
- Start date
- 2018-08-09
- Primary completion
- 2019-05-21
- Completion
- 2019-05-21
- First posted
- 2022-05-31
- Last updated
- 2024-01-22
- Results posted
- 2024-01-22
Locations
1 site across 1 country: United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05396742. Inclusion in this directory is not an endorsement.