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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: Completed Phase 1 study, sponsored by Kynexis B.V..
NCT06225115 is a Phase 1 study that has completed, run by Kynexis B.V.. The registered enrollment target is 72 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
All cohorts
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 |
What the finished NCT06225115 record still lists
NCT06225115 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT06225115 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06225115's enrollment target sits among peer trials
72 736th of 2000 higher than 1,254 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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