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A Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of KA34 in Subjects With Knee Osteoarthritis

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03133676
Recruitment Status : Completed
First Posted : April 28, 2017
Last Update Posted : September 3, 2020
Sponsor:
Collaborator:
California Institute for Regenerative Medicine (CIRM)
Information provided by (Responsible Party):
Calibr, a division of Scripps Research

Brief Summary:
This study will evaluate the safety and tolerability of KA34 when administered via intra-articular injection to subjects with osteoarthritis of the knee.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: KA34 Drug: Placebo Phase 1

Detailed Description:
This is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of KA34 when administered via intra-articular injection to subjects with osteoarthritis of the knee. OA patients are randomized to receive either placebo or KA34 active drug in the range of 50-400 ug by intra-articular injection. The first portion of the study is with single ascending doses, the second portion of the study is with multiple ascending doses.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of KA34 Administered Via Intra-Articular Injection in Subjects With Osteoarthritis of the Knee
Actual Study Start Date : May 2, 2018
Actual Primary Completion Date : April 28, 2020
Actual Study Completion Date : April 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: KA34 Active Drug
KA34 active drug in the dose range of 50 - 400 ug per knee
Drug: KA34
50 µg - 400 µg intra-articular injection (single or multiple doses)
Other Name: KA-34

Placebo Comparator: Placebo
Placebo is the formulation for KA34.
Drug: Placebo
50 µg - 400 µg intra-articular injection (single or multiple doses)




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Day 29 or Day 180 ]
    Incidence, relatedness, severity, and duration of treatment emergent adverse events


Secondary Outcome Measures :
  1. Change from Baseline in Laboratory Tests [ Time Frame: Day 29 or Day 180 ]
    Change from baseline in clinical laboratory test results

  2. Change from Baseline in Vital Signs [ Time Frame: Day 29 or Day 180 ]
    Change from baseline in vital sign measurements

  3. Change from Baseline in ECG [ Time Frame: Day 29 or Day 180 ]
    Change from baseline in electrocardiogram results

  4. Physical Examination Findings [ Time Frame: Day 29 or Day 180 ]
    Clinically significant findings on physical examination

  5. Pharmacokinetic Parameter - Cmax [ Time Frame: Day 8 or Day 29 ]
    Maximum observed plasma concentration

  6. Pharmacokinetic Parameter - Tmax [ Time Frame: Day 8 or Day 29 ]
    Time to maximum observed plasma concentration

  7. Pharmacokinetic Parameter - AUC [ Time Frame: Day 8 or Day 29 ]
    Area under the plasma concentration vs. time curve

  8. Pharmacokinetic Parameter - t 1/2 [ Time Frame: Day 8 or Day 29 ]
    Terminal half-life

  9. Pharmacokinetic Parameter - CL/F [ Time Frame: Day 8 or Day 29 ]
    Apparent clearance

  10. Pharmacokinetic Parameter - Vz/F [ Time Frame: Day 8 or Day 29 ]
    Volume of distribution



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of localized osteoarthritis of the knee
  • Males willing to use contraception and females who are no longer able to bear children

Exclusion Criteria:

  • Body Mass Index (BMI) > 40
  • Grade 0, 3 or 4 osteoarthritis on the Kellgren and Lawrence classification system
  • Injury to the knee or other joint within the last 12 months
  • Receipt of any investigational product or experimental therapeutic procedure within the last 12 weeks

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 ClinicalTrials.gov identifier (NCT number): NCT03133676


Locations
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United States, California
Diablo Clinical Research
Walnut Creek, California, United States, 94598
United States, Florida
Clinical Research of West Florida
Clearwater, Florida, United States, 33765
Bioclinica Research
Orlando, Florida, United States, 32806
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Sponsors and Collaborators
Calibr, a division of Scripps Research
California Institute for Regenerative Medicine (CIRM)
Investigators
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Study Director: Martin Lotz, MD Calibr, a division of Scripps Research
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Responsible Party: Calibr, a division of Scripps Research
ClinicalTrials.gov Identifier: NCT03133676    
Other Study ID Numbers: CBR-KA34-3001
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Calibr, a division of Scripps Research:
Osteoarthritis
Arthritis
Joint Disease
Osteoarthritis, Knee
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases