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

Calibr, a division of Scripps Research

Status and phase: Completed; Phase 1

Conditions: Osteoarthritis, Knee

Treatments: Drug: KA34; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03133676

CBR-KA34-3001

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

KA34 Active Drug

Experimental group

Description:

KA34 active drug in the dose range of 50 - 400 ug per knee

Treatment:

Drug: KA34

Placebo

Placebo Comparator group

Description:

Placebo is the formulation for KA34.

Treatment:

Drug: Placebo