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NCT04497662 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of KPL-404 in Healthy Subjects
A Phase 1 study, sponsored by Kiniksa Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT04497662: Completed Phase 1 study, sponsored by Kiniksa Pharmaceuticals.
NCT04497662 is a Phase 1 study that has completed, run by Kiniksa Pharmaceuticals. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04497662, a Phase 1 study, has completed, sponsored by Kiniksa Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
Phase 1, randomized, double-blind, placebo-controlled first-in-human study to investigate the safety, tolerability, PK and PD properties of single ascending intravenous (IV) and subcutaneous (SC) doses of KPL-404 in healthy subjects
Primary Outcome
After single ascending IV doses, number of subjects with treatment-emergent adverse events (TEAEs) in the KPL-404 dose-level cohorts compared with the (pooled) IV placebo group
Interventions
- OTHER Matching Placebo
- DRUG KPL-404
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2019-10-22 |
| Est. Completion | 2021-03-02 |
| Phase | Phase 1 |
What the finished NCT04497662 record still lists
NCT04497662 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 2 interventions - of which Matching Placebo is the first listed.
NCT04497662 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04497662 about?
NCT04497662 is a clinical study titled "Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of KPL-404 in Healthy Subjects". Phase 1, randomized, double-blind, placebo-controlled first-in-human study to investigate the safety, tolerability, PK and PD properties of single ascending intravenous (IV) and subcutaneous (SC) doses of KPL-404 in healthy subjects
What is the current status of trial NCT04497662?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2019-10-22. Estimated completion is 2021-03-02.
What interventions are being tested in trial NCT04497662?
The interventions under investigation include: Matching Placebo (OTHER), KPL-404 (DRUG).
Who is sponsoring clinical trial NCT04497662?
This trial is sponsored by Kiniksa Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04497662's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 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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