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NCT04324268 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Safety, Tolerability, and Bioavailability of Subcutaneous Lirentelimab (AK002) in Adult Healthy Volunteers
A Phase 1 study of Study Conducted in Healthy Volunteers, sponsored by Allakos.
- Completed
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
- 1
- Study location
NCT04324268 is a Phase 1 study of Study Conducted in Healthy Volunteers that has completed, run by Allakos. The registered enrollment target is 66 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04324268, a Phase 1 study of Study Conducted in Healthy Volunteers, has completed, sponsored by Allakos.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1, single-center study to evaluate safety, tolerability, and bioavailability of subcutaneously administered lirentelimab (AK002) in adult healthy volunteers. Subjects will receive a single dose of intravenous AK002 or subcutaneous lirentelimab (AK002) assigned in a double-blind, randomized fashion.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG lirentelimab (AK002)
Study Locations (1)
Florida
- Allakos Investigational Site - Edgewater
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2020-03-23 |
| Est. Completion | 2021-02-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04324268
The ClinicalTrials.gov registry entry for NCT04324268 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allakos, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Study Conducted in Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04324268 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT04324268 about?
NCT04324268 is a clinical study titled "A Study to Evaluate Safety, Tolerability, and Bioavailability of Subcutaneous Lirentelimab (AK002) in Adult Healthy Volunteers". This is a Phase 1, single-center study to evaluate safety, tolerability, and bioavailability of subcutaneously administered lirentelimab (AK002) in adult healthy volunteers. Subjects will receive a single dose of intravenous AK002 or subcutaneous lirentelimab (AK002) assigned in a double-blind, rand...
What is the current status of trial NCT04324268?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2020-03-23. Estimated completion is 2021-02-10.
What conditions does trial NCT04324268 study?
This clinical trial studies the following conditions: Study Conducted in Healthy Volunteers.
What interventions are being tested in trial NCT04324268?
The interventions under investigation include: Placebo (OTHER), lirentelimab (AK002) (DRUG).
Who is sponsoring clinical trial NCT04324268?
This trial is sponsored by Allakos, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04324268 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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