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NCT03133676 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of KA34 in Subjects With Knee Osteoarthritis
A Phase 1 study, sponsored by Calibr, a division of Scripps Research.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT03133676: Completed Phase 1 study, sponsored by Calibr, a division of Scripps Research.
NCT03133676 is a Phase 1 study that has completed, run by Calibr, a division of Scripps Research. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03133676, a Phase 1 study, has completed, sponsored by Calibr, a division of Scripps Research.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
This study will evaluate the safety and tolerability of KA34 when administered via intra-articular injection to subjects with osteoarthritis of the knee.
Primary Outcome
TEAEs were collected from time of first administration of IP (Day 1) until 28 days after the last administration of IP. The severity of TEAEs was classified by the investigator as mild, moderate or severe and graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The investigator also assessed relatedness of TEAEs. The number of subjects who experienced any TEAEs, serious TEAEs (SAE), related TEAEs and TEAEs with CTCAE Grade ≥ 3 are presented.
Interventions
- DRUG Placebo
- DRUG KA34
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2018-05-02 |
| Est. Completion | 2020-04-28 |
| Phase | Phase 1 |
What the finished NCT03133676 record still lists
NCT03133676 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03133676 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03133676 about?
NCT03133676 is a clinical study titled "A Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of KA34 in Subjects With Knee Osteoarthritis". This study will evaluate the safety and tolerability of KA34 when administered via intra-articular injection to subjects with osteoarthritis of the knee.
What is the current status of trial NCT03133676?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2018-05-02. Estimated completion is 2020-04-28.
What interventions are being tested in trial NCT03133676?
The interventions under investigation include: Placebo (DRUG), KA34 (DRUG).
Who is sponsoring clinical trial NCT03133676?
This trial is sponsored by Calibr, a division of Scripps Research, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03133676's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 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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