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NCT05226923 · ClinicalTrials.gov registry record · Phase 1
Study of the Safety and Pharmacokinetics of KSP-1007 Alone and Coadministered With Meropenem in Healthy Subjects
A Phase 1 study of Bacterial Infections, sponsored by Sumitovant Biopharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 123
- Enrollment target
- 1
- Study location
NCT05226923: Completed Phase 1 study of Bacterial Infections, sponsored by Sumitovant Biopharma.
NCT05226923 is a Phase 1 study of Bacterial Infections that has completed, run by Sumitovant Biopharma. The registered enrollment target is 123 participants, roughly in line with the 134-participant average among 17 other Bacterial Infections trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05226923, a Phase 1 study of Bacterial Infections, has completed, sponsored by Sumitovant Biopharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 123 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a first-in-human, Phase 1, randomized, double- blind, four-part, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of single (Part 1) and repeat (Part 2) escalating intravenous doses of KSP-1007. Repeated escalating doses of KSP-1007 will be co-administered with meropenem (Part 3) and single, ascending doses of KSP-1007 will be administered alone in healthy Japanese subjects (Part 4)
Primary Outcome
Incidence of adverse events
Conditions Studied
Interventions
- DRUG Meropenem
- DRUG KSP-1007
- OTHER Placebo:0.9% sodium chloride
Study Locations (1)
Kansas
- PRA Health Sciences - Lenexa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2022-01-12 |
| Est. Completion | 2022-10-01 |
| Phase | Phase 1 |
What the finished NCT05226923 record still lists
NCT05226923 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 134-participant average among 17 other Bacterial Infections trials with a reported enrollment target.
The record links to 1 condition, with Bacterial Infections appearing as the primary indexed condition, and to 3 interventions - of which Meropenem is the first listed.
NCT05226923 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT05226923 about?
NCT05226923 is a clinical study titled "Study of the Safety and Pharmacokinetics of KSP-1007 Alone and Coadministered With Meropenem in Healthy Subjects". This study is a first-in-human, Phase 1, randomized, double- blind, four-part, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of single (Part 1) and repeat (Part 2) escalating intravenous doses of KSP-1007. Repeated escalating doses of KSP-1007 will be co-administered...
What is the current status of trial NCT05226923?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 123 participants. The study started on 2022-01-12. Estimated completion is 2022-10-01.
What conditions does trial NCT05226923 study?
This clinical trial studies the following conditions: Bacterial Infections.
What interventions are being tested in trial NCT05226923?
The interventions under investigation include: Meropenem (DRUG), KSP-1007 (DRUG), Placebo:0.9% sodium chloride (OTHER).
Who is sponsoring clinical trial NCT05226923?
This trial is sponsored by Sumitovant Biopharma, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05226923 being conducted?
This trial has 1 study location across Kansas. 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 NCT05226923's enrollment target sits among peer trials
123 4th of 17 higher than 14 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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