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NCT03918239 · ClinicalTrials.gov registry record · Phase 1
A Study to Determine the Bioavailability of Lanadelumab (SHP643) Administered Subcutaneously With the Prefilled Syringe and the Autoinjector in Healthy Adult Volunteer Participants.
A Phase 1 study, sponsored by Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 190
- Enrollment target
NCT03918239: Completed Phase 1 study, sponsored by Shire.
NCT03918239 is a Phase 1 study that has completed, run by Shire. The registered enrollment target is 190 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (217% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03918239, a Phase 1 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 190 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate bioavailability of lanadelumab (SHP643) following a single, 2 milliliter (mL) subcutaneous (SC) dose of 300 milligrams (mg) delivered by prefilled syringe (PFS) or auto injector (AI) in healthy adult participants.
Primary Outcome
AUC(0-last) of SHP643 in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
Interventions
- DRUG SHP643
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2019-05-14 |
| Est. Completion | 2019-11-13 |
| Phase | Phase 1 |
What the finished NCT03918239 record still lists
NCT03918239 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (217% higher).
The record links to 0 conditions, and to 1 intervention - of which SHP643 is the first listed.
NCT03918239 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03918239 about?
NCT03918239 is a clinical study titled "A Study to Determine the Bioavailability of Lanadelumab (SHP643) Administered Subcutaneously With the Prefilled Syringe and the Autoinjector in Healthy Adult Volunteer Participants.". The purpose of this study is to evaluate bioavailability of lanadelumab (SHP643) following a single, 2 milliliter (mL) subcutaneous (SC) dose of 300 milligrams (mg) delivered by prefilled syringe (PFS) or auto injector (AI) in healthy adult participants.
What is the current status of trial NCT03918239?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 190 participants. The study started on 2019-05-14. Estimated completion is 2019-11-13.
What interventions are being tested in trial NCT03918239?
The interventions under investigation include: SHP643 (DRUG).
Who is sponsoring clinical trial NCT03918239?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03918239's enrollment target sits among peer trials
190 284th of 2000 higher than 1,713 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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