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NCT04238364 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety, Tolerability and Amount of EI-1071 in Blood in Healthy Volunteers
A Phase 1 study of Healthy Volunteers, sponsored by Elixiron Immunotherapeutics (Hong Kong).
- Completed
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
- 1
- Study location
NCT04238364: Completed Phase 1 study of Healthy Volunteers, sponsored by Elixiron Immunotherapeutics (Hong Kong).
NCT04238364 is a Phase 1 study of Healthy Volunteers that has completed, run by Elixiron Immunotherapeutics (Hong Kong). The registered enrollment target is 58 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04238364, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Elixiron Immunotherapeutics (Hong Kong).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
- 1
- Study location
Study Summary
This was a first-in-human study to determine the safety, tolerability, and pharmacokinetics of EI1071 after single and multiple doses in healthy volunteers.
Primary Outcome
Experience at least 1 treatment-emergent adverse event
Conditions Studied
Interventions
- DRUG Placebo
- DRUG EI-1071
Study Locations (1)
Maryland
- Parexel Early Phase Clinical Unit - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2019-12-27 |
| Est. Completion | 2022-01-10 |
| Phase | Phase 1 |
What the finished NCT04238364 record still lists
NCT04238364 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04238364 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04238364 about?
NCT04238364 is a clinical study titled "A Study to Evaluate the Safety, Tolerability and Amount of EI-1071 in Blood in Healthy Volunteers". This was a first-in-human study to determine the safety, tolerability, and pharmacokinetics of EI1071 after single and multiple doses in healthy volunteers.
What is the current status of trial NCT04238364?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2019-12-27. Estimated completion is 2022-01-10.
What conditions does trial NCT04238364 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT04238364?
The interventions under investigation include: Placebo (DRUG), EI-1071 (DRUG).
Who is sponsoring clinical trial NCT04238364?
This trial is sponsored by Elixiron Immunotherapeutics (Hong Kong), which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04238364 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04238364's enrollment target sits among peer trials
58 124th of 283 higher than 158 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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.
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