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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 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.
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)
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05226923
The ClinicalTrials.gov registry entry for NCT05226923 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 123 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 134-participant average among 17 other Bacterial Infections trials with a reported enrollment target. The listed sponsor is Sumitovant Biopharma, which has 1 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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