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NCT02095548 · ClinicalTrials.gov registry record · Phase 1
Phase 1, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 in Moderate to Severe Knee Osteoarthritis (OA)
A Phase 1 study, sponsored by Biosplice Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
NCT02095548 is a Phase 1 study that has completed, run by Biosplice Therapeutics. The registered enrollment target is 61 participants.
The verdict
NCT02095548, a Phase 1 study, has completed, sponsored by Biosplice Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
Study Summary
The purpose of this study is to find the optimal dose of SM04690 that can be safely given by intra-articular injection into the target knee joint of subjects with moderate to severe osteoarthritis.
Interventions
- DRUG Placebo
- DRUG SM04690, 0.03mg/2mL
- DRUG SM04690, 0.07mg/2mL
- DRUG SM04690, 0.23mg/2mL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2014-03 |
| Est. Completion | 2015-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02095548
The ClinicalTrials.gov registry entry for NCT02095548 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biosplice Therapeutics, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02095548 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02095548 about?
NCT02095548 is a clinical study titled "Phase 1, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 in Moderate to Severe Knee Osteoarthritis (OA)". The purpose of this study is to find the optimal dose of SM04690 that can be safely given by intra-articular injection into the target knee joint of subjects with moderate to severe osteoarthritis.
What is the current status of trial NCT02095548?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2014-03. Estimated completion is 2015-09.
What interventions are being tested in trial NCT02095548?
The interventions under investigation include: Placebo (DRUG), SM04690, 0.03mg/2mL (DRUG), SM04690, 0.07mg/2mL (DRUG), SM04690, 0.23mg/2mL (DRUG).
Who is sponsoring clinical trial NCT02095548?
This trial is sponsored by Biosplice Therapeutics, which has 20 total clinical trials registered on ClinicalTrials.gov.
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