Overview

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

Status:
Completed
Trial end date:
2020-04-28
Target enrollment:
0
Participant gender:
All
Summary
This study will evaluate the safety and tolerability of KA34 when administered via intra-articular injection to subjects with osteoarthritis of the knee.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Calibr, a division of Scripps Research
California Institute for Biomedical Research
Collaborator:
California Institute for Regenerative Medicine (CIRM)
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