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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: Completed Phase 1 study, sponsored by Biosplice Therapeutics.

NCT02095548 is a Phase 1 study that has completed, run by Biosplice Therapeutics. The registered enrollment target is 61 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.

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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

FieldValue
Enrollment Target 61 participants
Start Date 2014-03
Est. Completion 2015-09
Phase Phase 1
Biosplice Therapeutics

20 total trials

What the finished NCT02095548 record still lists

NCT02095548 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 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 4 interventions - of which Placebo is the first listed.

NCT02095548 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02095548's enrollment target sits among peer trials

61 828th of 2000 higher than 1,170 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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Source: ClinicalTrials.gov NCT02095548, the US trial registry maintained by the National Library of Medicine. NCT02095548 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.