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

NCT ID: NCT03133676

Last Updated: 2022-12-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-02

Study Completion Date

2020-04-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Osteoarthritis, Knee

Keywords

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Osteoarthritis Arthritis Joint Disease Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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KA34 Active Drug

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

Group Type EXPERIMENTAL

KA34

Intervention Type DRUG

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

Placebo

Placebo is the formulation for KA34.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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KA34

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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KA-34

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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California Institute for Regenerative Medicine (CIRM)

OTHER

Sponsor Role collaborator

Calibr, a division of Scripps Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Lotz, MD

Role: STUDY_DIRECTOR

Calibr, a division of Scripps Research

Locations

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Diablo Clinical Research

Walnut Creek, California, United States

Site Status

Clinical Research of West Florida

Clearwater, Florida, United States

Site Status

Bioclinica Research

Orlando, Florida, United States

Site Status

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CBR-KA34-3001

Identifier Type: -

Identifier Source: org_study_id