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NCT04503603 · ClinicalTrials.gov registry record · Phase 1
A Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lanadelumab Administered Intravenously in Healthy Adult Volunteer Participants
A Phase 1 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT04503603: Completed Phase 1 study, sponsored by Takeda.
NCT04503603 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04503603, a Phase 1 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study to evaluate the safety, tolerability and pharmacokinetics (PK) of lanadelumab administered by Intravenous (IV) infusion in healthy adult volunteers.
Primary Outcome
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study that did not necessarily have a causal relationship with the treatment. TEAEs were events that occurred on or after the date and time of administration of the first dose of study medication. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with TEAEs were reported.
Interventions
- OTHER Placebo
- DRUG Lanadelumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2020-08-10 |
| Est. Completion | 2020-12-23 |
| Phase | Phase 1 |
What the finished NCT04503603 record still lists
NCT04503603 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04503603 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04503603 about?
NCT04503603 is a clinical study titled "A Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lanadelumab Administered Intravenously in Healthy Adult Volunteer Participants". The purpose of this study to evaluate the safety, tolerability and pharmacokinetics (PK) of lanadelumab administered by Intravenous (IV) infusion in healthy adult volunteers.
What is the current status of trial NCT04503603?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2020-08-10. Estimated completion is 2020-12-23.
What interventions are being tested in trial NCT04503603?
The interventions under investigation include: Placebo (OTHER), Lanadelumab (DRUG).
Who is sponsoring clinical trial NCT04503603?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04503603's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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