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NCT03401671 · ClinicalTrials.gov registry record · Phase 1
Study of Lanadelumab in Healthy Japanese and Matched Caucasian Adult Subjects
A Phase 1 study of Healthy Volunteers, sponsored by Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT03401671: Completed Phase 1 study of Healthy Volunteers, sponsored by Shire.
NCT03401671 is a Phase 1 study of Healthy Volunteers that has completed, run by Shire. The registered enrollment target is 32 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03401671, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Cmax is the maximum observed plasma concentration of Lanadelumab was presented. Geometric mean and geometric coefficient of variation percent (CV%) was presented.
Conditions Studied
Interventions
- DRUG Lanadelumab
Study Locations (1)
California
- WCCT Global, Inc. - Cypress
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2018-01-15 |
| Est. Completion | 2018-05-30 |
| Phase | Phase 1 |
What the finished NCT03401671 record still lists
NCT03401671 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which Lanadelumab is the first listed.
NCT03401671 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03401671 about?
NCT03401671 is a clinical study titled "Study of Lanadelumab in Healthy Japanese and Matched Caucasian Adult Subjects". 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.
What is the current status of trial NCT03401671?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2018-01-15. Estimated completion is 2018-05-30.
What conditions does trial NCT03401671 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT03401671?
The interventions under investigation include: Lanadelumab (DRUG).
Who is sponsoring clinical trial NCT03401671?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03401671 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Volunteers
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03401671's enrollment target sits among peer trials
32 171st of 283 higher than 99 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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