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A Safety and Tolerability Study of UBX0101 in Patients With Osteoarthritis of the Knee

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03513016
Recruitment Status : Recruiting
First Posted : May 1, 2018
Last Update Posted : August 29, 2018
Information provided by (Responsible Party):
Unity Biotechnology, Inc.

Brief Summary:
A study to evaluate safety, tolerability, and pharmacokinetics of a single intra-articular injection of UBX0101 in patients diagnosed with painful osteoarthritis of the knee.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: UBX0101 Other: Placebo Phase 1

Detailed Description:

This study is a phase 1, randomized, double-blind, placebo-controlled single ascending dose study that will evaluate safety, tolerability, and pharmacokinetics of UBX0101 in patients diagnosed with painful femoro-tibial osteoarthritis.

Patients will be randomly allocated to receive UBX0101 or placebo in 3:1 randomization by dose level (cohort).

The primary objective is to establish the safety and tolerability of UBX0101 given as a single intra-articular injection into the femoro-tibial joint of patients with osteoarthritis.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Double-Blind, Randomized, Placebo Controlled, Single Ascending Dose Study to Assess the Safety and Tolerability of UBX0101 in Moderate to Severe, Painful Osteoarthritis of the Knee
Actual Study Start Date : May 16, 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: UBX0101
UBX0101, single intra-articular injection, ascending dose
Drug: UBX0101
Investigational drug intra-articular injection

Placebo Comparator: Placebo
Placebo, single intra-articular injection, ascending dose
Other: Placebo
Diluent intra-articular injection

Primary Outcome Measures :
  1. Safety and tolerability of a single intra articular injection of UBX0101 evaluated by the incidence of serious and non-serious adverse events [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Plasma concentration of UBX0101 over 24 hrs following a single intra-articular injection [ Time Frame: 24 hrs ]
  2. The change from baseline to Week 12 of the weekly mean of the average daily pain intensity score as obtained using the 11-point numerical rating scale [0-10] where 0 represents no pain and 10 represents worst pain imaginable [ Time Frame: Baseline to Week 12 ]
  3. The change from baseline to Week 12 for the Western Ontario and McMaster Universities (WOMAC) index total score and the pain and function subscales using the 5-point Likert scale [ Time Frame: Baseline to Week 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who have the capacity to give informed consent and who are willing to comply with all study related procedures and assessments. Patients who do not have the legal capacity or medical competency to give written informed consent are not eligible for this study; consent via legally authorized representative will not be accepted
  • Patients must be ≥ 40 and ≤ 85 years of age
  • Ambulatory persons with osteoarthritis (OA) of the knee and baseline pain with a mean of ≥ 4 and ≤ 9 points on the 24-hour mean pain score (on the 11-point Numeric Rating Scale) for at least five of the seven days during the screening period.
  • Patients using non-steroidal anti-inflammatory agent must be on a consistent regimen, dose, and medication for at least 8 weeks prior to enrollment

Exclusion Criteria:

  • Any condition, including laboratory findings and findings in the medical history or in the pre-study assessments, that in the opinion of the Investigator constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation or prevent the Patient from fully participating in all aspects of the study
  • Patients with clinically significant co-existing conditions of the cardiovascular, renal, gastrointestinal, respiratory, nervous, metabolic, or hematologic/ immune systems
  • Patients with a history of diabetes mellitus according to the American Diabetes Association criteria or patients previously diagnosed by a qualified physician as having diabetes (American Diabetes Association Standards of Medical Care in Diabetes 2016)
  • Patients with a history of cardiac rhythm disturbances, abnormal ECG intervals, or use of medications known to impact ECG intervals
  • Patients who have undergone diagnostic arthroscopy of the Target Knee in the previous six months
  • Patients who have undergone arthroscopic surgery in the last two years prior to the screening visit (including microfracture and menisectomy) on the Target Knee.
  • Patients anticipated to have arthroscopic surgery on either knee at any time during the study period
  • History of previous total or partial knee arthroplasty in either knee
  • Patients with an effusion at the screening visit which, in the opinion of the investigator following examination and discussions with the Patient, requires drainage for symptom relief
  • Patients who have received intra-articular treatment with steroids or hyaluronic acid derivatives within the last 16 weeks prior to screening
  • Patients who use, or have used in the 8 weeks prior to screening, opioid analgesics (with exception of mild opioid analgesics)
  • Patients who have had regenerative joint procedures on any joint including, but not limited to, platelet-rich plasma injections, mesenchymal stem cell transplantation, autologous chondrocyte transplantation, or mosaicplasty
  • Current or history of other joint diseases such as joint dysplasia, crystal-induced arthropathy (such as gout, or calcium pyrophosphate deposition disease evidenced by clinical and/or radiographic means), aseptic osteonecrosis, acromegaly, Paget's disease, Ehlers-Danlos Syndrome, Gaucher's disease, Stickler's syndrome, joint infection, hemophilia, hemochromatosis, or neuropathic arthropathy of any cause
  • Any active known or suspected systemic autoimmune disease (except for vitiligo, residual auto-immune hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment for two years, conditions not expected to recur in the absence of an external trigger) or any history of a systemic inflammatory arthritis such as psoriatic, rheumatoid, ankylosing spondylitis or reactive arthritis
  • Patients diagnosed presently and symptomatic with fibromyalgia based on ACR Criteria
  • Patients with a BMI ≥ 40 kg/m2, or whose size exceed the limits of the of the MRI equipment (coil and gantry)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03513016

Contact: Clinical Trials at UNITY 888-563-6762

United States, Florida
Well Pharma Medical Research Recruiting
Miami, Florida, United States, 33132
Contact: Elissa Doens    305-665-4818      
United States, Pennsylvania
Altoona Center for Clinical Research Recruiting
Duncansville, Pennsylvania, United States, 16635
Contact: Lisa Claycomb    814-693-0300      
United States, Texas
Metroplex Clinical Research Center Recruiting
Dallas, Texas, United States, 75231
Contact: Cindy Caberera    214-424-0400      
Sponsors and Collaborators
Unity Biotechnology, Inc.
Study Chair: Jamie Dananberg, MD UNITY Biotechnology

Responsible Party: Unity Biotechnology, Inc. Identifier: NCT03513016     History of Changes
Other Study ID Numbers: UBX0101-OAR-101
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Unity Biotechnology, Inc.:
Painful Osteoarthritis
Osteoarthritis, Knee

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases