Phase 1, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 in Moderate to Severe Knee Osteoarthritis (OA)

ClinicalTrials.gov ID: NCT02095548

Public ClinicalTrials.gov record NCT02095548. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

A Phase 1, Placebo-Controlled, Double-Blind, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT02095548
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Biosplice Therapeutics, Inc.; Industry
Enrollment: 61 participants

Conditions and interventions

Conditions

Moderate to Severe Osteoarthritis

Interventions

Drug

Eligibility (public fields only)

Age range: 50 Years to 75 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 2014 (Type not available)
Primary completion: Sep 2015 (Actual)
Completion: Sep 2015 (Actual)
Last update posted: Dec 10, 2015

2014 – 2015

United States locations

U.S. sites: 7
U.S. states: 6
U.S. cities: 7

Facility	City	State	ZIP	Site status
Not listed	Tucson	Arizona	—	—
Not listed	El Cajon	California	—	—
Not listed	Walnut Creek	California	—	—
Not listed	Miami	Florida	—	—
Not listed	Boston	Massachusetts	—	—
Not listed	Duncansville	Pennsylvania	—	—
Not listed	Dallas	Texas	—	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02095548, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Dec 10, 2015 · Synced Nov 6, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02095548 live on ClinicalTrials.gov.

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