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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03133676
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Calibr, a division of Scripps Research
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis, Knee

Arms & Interventions

Arms

Experimental: KA34

KA34

Placebo Comparator: Placebo

Placebo

Interventions

Drug: - KA34

50 µg - 400 µg intra-articular injection (single or multiple doses)

Drug: - Placebo

50 µg - 400 µg intra-articular injection (single or multiple doses)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Diablo Clinical Research, Walnut Creek, California

Status

Recruiting

Address

Diablo Clinical Research

Walnut Creek, California, 94598

Site Contact

Ava Paulazzo

[email protected]

925-930-7267

Clinical Research of West Florida, Clearwater, Florida

Status