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



Status:Recruiting
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:40 - 75
Updated:1/23/2019
Start Date:May 2, 2018
End Date:February 2020
Contact:Alma Villasin, RN, BSN, MBA
Email:Alma.villasin@IQVIA.com
Phone:+1 856 473 5374

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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

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


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
We found this trial at
4
sites
Duncansville, Pennsylvania 16635
Principal Investigator: Alan Kivitz
Phone: 814-296-6101
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Duncansville, PA
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2147 Northeast Coachman Road
Clearwater, Florida 33765
Principal Investigator: Robert Levin
Phone: 727-466-0078
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Clearwater, FL
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100 West Gore Street
Orlando, Florida 32806
Principal Investigator: Judith White, M.D.
Phone: 407-426-9299
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Orlando, FL
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Walnut creek, California 94598
Principal Investigator: Leonard Chuck
Phone: 925-930-7267
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Walnut creek, CA
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