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

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ClinicalTrials.gov Identifier: NCT03133676
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : June 27, 2018
Sponsor:
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

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: KA34
KA34
Drug: KA34
50 µg - 400 µg intra-articular injection (single or multiple doses)

Placebo Comparator: Placebo
Placebo
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 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


Contacts
Contact: Alma Villasin, RN, BSN, MBA +1 856 473 5374 Alma.villasin@IQVIA.com

Locations
United States, California
Diablo Clinical Research Recruiting
Walnut Creek, California, United States, 94598
Contact: Ava Paulazzo    925-930-7267      
Principal Investigator: Leonard Chuck         
United States, Florida
Clinical Research of West Florida Recruiting
Clearwater, Florida, United States, 33765
Contact    727-466-0078    Research@crwf.com   
Principal Investigator: Robert Levin         
Bioclinica Research Recruiting
Orlando, Florida, United States, 32806
Contact: Jason Gonyea    407-426-9299    Jason.Gonyea@bioclinica.com   
Principal Investigator: Judith White, M.D.         
United States, Pennsylvania
Altoona Center for Clinical Research Recruiting
Duncansville, Pennsylvania, United States, 16635
Contact: Lisa Claycomb    814-296-6101      
Principal Investigator: Alan Kivitz         
Sponsors and Collaborators
Calibr, a division of Scripps Research

Responsible Party: Calibr, a division of Scripps Research
ClinicalTrials.gov Identifier: NCT03133676     History of Changes
Other Study ID Numbers: CBR-KA34-3001
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases