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NCT04482569 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of XNW4107 Alone or in Combination With Imipenem/Cilastatin
A Phase 1 study of Bacterial Infections, sponsored by Evopoint Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 88
- Enrollment target
- 1
- Study location
NCT04482569: Completed Phase 1 study of Bacterial Infections, sponsored by Evopoint Biosciences.
NCT04482569 is a Phase 1 study of Bacterial Infections that has completed, run by Evopoint Biosciences. The registered enrollment target is 88 participants, below the 136-participant average among 17 other Bacterial Infections trials with a reported enrollment target (35% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04482569, a Phase 1 study of Bacterial Infections, has completed, sponsored by Evopoint Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 88 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a 3-part, first-in-human study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of XNW4107 given as intravenous (IV) infusion in healthy male subjects. In part 1, subjects will receive a single dose of XNW4107. In part 2, subjects will receive XNW4107 for 7 days. In Part 3, subjects will receive XNW4107 in combination with imipenem/cilastatin for 14 days.
Primary Outcome
Number of participants who experience adverse events in different grades, as defined by Common Terminology for Adverse Events (CTCAE) v5.0
Conditions Studied
Interventions
- DRUG XNW4107
Study Locations (1)
Maryland
- Pharmaron CPC - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2020-07-10 |
| Est. Completion | 2021-09-30 |
| Phase | Phase 1 |
What the finished NCT04482569 record still lists
NCT04482569 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 136-participant average among 17 other Bacterial Infections trials with a reported enrollment target (35% lower).
The record links to 1 condition, with Bacterial Infections appearing as the primary indexed condition, and to 1 intervention - of which XNW4107 is the first listed.
NCT04482569 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04482569 about?
NCT04482569 is a clinical study titled "Study to Evaluate Safety, Tolerability, and Pharmacokinetics of XNW4107 Alone or in Combination With Imipenem/Cilastatin". This is a 3-part, first-in-human study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of XNW4107 given as intravenous (IV) infusion in healthy male subjects. In part 1, subjects will receive a single dose of XNW4107. In part 2, subjects will receive XNW4107 for 7 days....
What is the current status of trial NCT04482569?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 88 participants. The study started on 2020-07-10. Estimated completion is 2021-09-30.
What conditions does trial NCT04482569 study?
This clinical trial studies the following conditions: Bacterial Infections.
What interventions are being tested in trial NCT04482569?
The interventions under investigation include: XNW4107 (DRUG).
Who is sponsoring clinical trial NCT04482569?
This trial is sponsored by Evopoint Biosciences, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04482569 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
Similar trials for Bacterial Infections
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 NCT04482569's enrollment target sits among peer trials
88 5th of 17 higher than 13 of 17 other Bacterial Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bacterial Infections 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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