Trial · NCT03246399
A Study of the Safety, Tolerability, and Pharmacokinetics of SM04690 Injectable Suspension Following Single Intradiscal Injection in Subjects With Degenerative Disc Disease
NCT03246399, Phase 1, Terminated, Biosplice Therapeutics, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of the Safety, Tolerability, and Pharmacokinetics of SM04690 Injectable Suspension Following Single Intradiscal Injection in Subjects With Degenerative Disc Disease. Trials, record NCT03246399. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03246399
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Safety, Tolerability, and Pharmacokinetics of SM04690 Injectable Suspension Following Single Intradiscal Injection in Subjects With Degenerative Disc Disease
- NCT number
- NCT03246399
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 6 participants, actual
- Lead sponsor
- Biosplice Therapeutics, Inc.
- Conditions
- Degenerative Disc Disease
- Interventions
- SM04690
- First posted
- 2017-08-11
- Last updated
- 2019-04-23
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and tolerability: treatment emergent adverse events (TEAEs) | Day 180 | Evaluate the safety and tolerability of SM04690 Injectable Suspension as measured by TEAEs during the entire treatment and observation period |
| Primary | Safety and tolerability: change from baseline in electrocardiogram (ECG) parameters | Baseline and Day 180 | Evaluate the safety and tolerability of SM04690 Injectable Suspension as measured by change from baseline in ECG parameters |
| Primary | Safety and tolerability: change from baseline in physical examination | Baseline and Day 180 | Evaluate the safety and tolerability of SM04690 Injectable Suspension as measured by change from baseline in physical examination (number of subjects with clinically significant change in physical examination) |
| Primary | Safety and tolerability: change from baseline in clinical laboratory tests | Baseline and Day 180 | Evaluate the safety and tolerability of SM04690 Injectable Suspension as measured by change from baseline in clinical laboratory tests (number of subjects with clinically significant changes in laboratory test parameters) |
| Primary | Safety and tolerability: change from baseline in vital signs | Baseline and Day 180 | Evaluate the safety and tolerability of SM04690 Injectable Suspension as measured by change from baseline in vital signs (number of subjects with clinically significant changes in vital signs) |
| Primary | Incidence of dose-limiting toxicities (DLTs) | Day 180 | Evaluate incidence and severity of DLTs in each cohort |
| Primary | Pharmacokinetics (PK) of SM04690: Cmax | Day 1 | Maximum plasma concentration (Cmax) estimate for a single intradiscal injection of SM04690 Injectable Suspension |
| Primary | PK of SM04690: tmax | Day 1 | Time to Cmax estimate for a single intradiscal injection of SM04690 Injectable Suspension |
| Primary | PK of SM04690: AUC | Day 1 | Area under the plasma-concentration time curve (AUC) estimate for a single intradiscal injection of SM04690 Injectable Suspension |
| Primary | PK of SM04690: half-life | Day 1 | Plasma terminal phase half-life estimate for a single intradiscal injection of SM04690 Injectable Suspension |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03246399
GET https://conductscience.org/api/trials/v1/NCT03246399/registered