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NCT04228302 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Pharmacokinetics of Oral EC5026 in Healthy Subjects
A Phase 1 study of Healthy Adults, sponsored by EicOsis Human Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT04228302: Completed Phase 1 study of Healthy Adults, sponsored by EicOsis Human Health.
NCT04228302 is a Phase 1 study of Healthy Adults that has completed, run by EicOsis Human Health. The registered enrollment target is 40 participants, below the 85-participant average among 33 other Healthy Adults trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04228302, a Phase 1 study of Healthy Adults, has completed, sponsored by EicOsis Human Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a first-in-human study with EC5026, a new drug candidate intended to treat neuropathic pain. The purpose of the study is to provide initial safety, tolerability, and pharmacokinetics data of single ascending oral doses of EC5026 in healthy subjects.
Primary Outcome
All AEs reported or observed during the study will be recorded on the electronic case report forms (eCRF). Information to be collected includes drug treatment, type of event, time of onset, dosage, investigator-specified assessment of severity and relationship to study drug, time of resolution of the event, seriousness, any required treatment or evaluations, and outcome. Any AEs resulting from concurrent illnesses, reactions to concurrent illnesses, reactions to concurrent medications, or progre
Conditions Studied
Interventions
- DRUG EC5026 oral capsule
- OTHER Placebo oral capsule
Study Locations (1)
Texas
- PPD Phase I Clinic - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-12-09 |
| Est. Completion | 2020-07-07 |
| Phase | Phase 1 |
What the finished NCT04228302 record still lists
NCT04228302 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 85-participant average among 33 other Healthy Adults trials with a reported enrollment target (53% lower).
The record links to 1 condition, with Healthy Adults appearing as the primary indexed condition, and to 2 interventions - of which EC5026 oral capsule is the first listed.
NCT04228302 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04228302 about?
NCT04228302 is a clinical study titled "Safety, Tolerability, and Pharmacokinetics of Oral EC5026 in Healthy Subjects". This is a first-in-human study with EC5026, a new drug candidate intended to treat neuropathic pain. The purpose of the study is to provide initial safety, tolerability, and pharmacokinetics data of single ascending oral doses of EC5026 in healthy subjects.
What is the current status of trial NCT04228302?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2019-12-09. Estimated completion is 2020-07-07.
What conditions does trial NCT04228302 study?
This clinical trial studies the following conditions: Healthy Adults.
What interventions are being tested in trial NCT04228302?
The interventions under investigation include: EC5026 oral capsule (DRUG), Placebo oral capsule (OTHER).
Who is sponsoring clinical trial NCT04228302?
This trial is sponsored by EicOsis Human Health, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04228302 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Adults
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04228302's enrollment target sits among peer trials
40 12th of 33 higher than 19 of 33 other Healthy Adults trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Adults 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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