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NCT03246399 · ClinicalTrials.gov registry record · Phase 1
A Study of the Safety, Tolerability, and Pharmacokinetics of SM04690 Injectable Suspension Following Single Intradiscal Injection in Subjects With Degenerative Disc Disease
A Phase 1 study, sponsored by Biosplice Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT03246399 is a Phase 1 study that was terminated before completion, run by Biosplice Therapeutics. The registered enrollment target is 6 participants.
The verdict
NCT03246399, a Phase 1 study, was terminated before completion, sponsored by Biosplice Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
SM04690-DDD-01 is a Phase 1, open-label, dose escalation study. SM04690 Injectable Suspension will be administered via a single intradiscal injection to subjects with degenerative disc disease (DDD) under fluoroscopic guidance. Groups of 6 subjects will be enrolled in successive cohorts. Subjects will participate in a 6 month follow-up period. Clinic visits will be Screening, Treatment Visit Day 1, and Follow-up Visit Days 2, 15, 28, 60, 90, 135, and 180.
Interventions
- DRUG SM04690
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2017-07-26 |
| Est. Completion | 2018-12-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03246399
The ClinicalTrials.gov registry entry for NCT03246399 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 6 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 1 intervention - of which SM04690 is the first listed.
NCT03246399 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03246399 about?
NCT03246399 is a clinical study titled "A Study of the Safety, Tolerability, and Pharmacokinetics of SM04690 Injectable Suspension Following Single Intradiscal Injection in Subjects With Degenerative Disc Disease". SM04690-DDD-01 is a Phase 1, open-label, dose escalation study. SM04690 Injectable Suspension will be administered via a single intradiscal injection to subjects with degenerative disc disease (DDD) under fluoroscopic guidance. Groups of 6 subjects will be enrolled in successive cohorts. Subjects wi...
What is the current status of trial NCT03246399?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2017-07-26. Estimated completion is 2018-12-04.
What interventions are being tested in trial NCT03246399?
The interventions under investigation include: SM04690 (DRUG).
Who is sponsoring clinical trial NCT03246399?
This trial is sponsored by Biosplice Therapeutics, which has 20 total clinical trials registered on ClinicalTrials.gov.
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