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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 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.

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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.

Conditions Studied

Interventions

  • DRUG Lanadelumab

Study Locations (1)

California

  • WCCT Global, Inc. - Cypress

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2018-01-15
Est. Completion 2018-05-30
Phase Phase 1

Sponsor

Shire

245 total trials

What the Registry Record Tells You About NCT03401671

The ClinicalTrials.gov registry entry for NCT03401671 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (93% lower). The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.