Trials / Completed
CompletedNCT03401671
Study of Lanadelumab in Healthy Japanese and Matched Caucasian Adult Subjects
A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of a Single Dose of Lanadelumab Administered Subcutaneously in Healthy Adult Japanese Subjects and Matched Healthy Adult Caucasian Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability and pharmacodynamics (PD) of lanadelumab in healthy adult Japanese subjects and matched non-Hispanic healthy adult Caucasian subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lanadelumab | SC injection of 300mg in 2mL (150 mg/mL) solution of lanadelumab will be administered as a single dose injection in the abdomen. |
Timeline
- Start date
- 2018-01-15
- Primary completion
- 2018-05-30
- Completion
- 2018-05-30
- First posted
- 2018-01-17
- Last updated
- 2021-06-03
- Results posted
- 2019-07-29
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03401671. Inclusion in this directory is not an endorsement.