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NCT06225115 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of KYN-5356 in Healthy Subjects Aged 18 to 55 Years
A Phase 1 study, sponsored by Kynexis B.V..
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
NCT06225115 is a Phase 1 study that has completed, run by Kynexis B.V.. The registered enrollment target is 72 participants.
The verdict
NCT06225115, a Phase 1 study, has completed, sponsored by Kynexis B.V..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
Study Summary
This first-in-human clinical trial with a randomized, double-blind, placebo-controlled, dose-escalation study design is regarded as standard to test the safety, tolerability, and pharmacokinetics of KYN-5356. The study comprises 3 parts: Part 1: Single Ascending Dose study Part 2: Multiple Ascending Dose study Part 3: Food Effect study The aim of Parts 1 and 2 of the study is to evaluate the safety and tolerability following single and multiple ascending doses of KYN-5356. The secondary aim is to evaluate the pharmacokinetics (PK) of escalating single and multiple doses of KYN-5356. In Part 2, cerebrospinal fluid will be sampled to explore PK and pharmacodynamic effects of KYN-5356. The potential effect of food intake on the disposition of KYN-5356 following a single oral dose will be evaluated in Part 3. Part 3 is an open-label, randomized, 2 period, 2 sequence design.
Interventions
- DRUG placebo
- DRUG KYN-5356
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2023-12-21 |
| Est. Completion | 2024-10-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06225115
The ClinicalTrials.gov registry entry for NCT06225115 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kynexis B.V., which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT06225115 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06225115 about?
NCT06225115 is a clinical study titled "A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of KYN-5356 in Healthy Subjects Aged 18 to 55 Years". This first-in-human clinical trial with a randomized, double-blind, placebo-controlled, dose-escalation study design is regarded as standard to test the safety, tolerability, and pharmacokinetics of KYN-5356. The study comprises 3 parts: Part 1: Single Ascending Dose study Part 2: Multiple Ascendi...
What is the current status of trial NCT06225115?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2023-12-21. Estimated completion is 2024-10-07.
What interventions are being tested in trial NCT06225115?
The interventions under investigation include: placebo (DRUG), KYN-5356 (DRUG).
Who is sponsoring clinical trial NCT06225115?
This trial is sponsored by Kynexis B.V., which has 2 total clinical trials registered on ClinicalTrials.gov.
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