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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: Completed Phase 1 study of Study Conducted in Healthy Volunteers, sponsored by Allakos.
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT04324268 record still lists
NCT04324268 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04324268's enrollment target sits among peer trials
66 786th of 2000 higher than 1,203 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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