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

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
KA34
Placebo
Sponsored by
Calibr, a division of Scripps Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Arthritis, Joint Disease, Osteoarthritis, Knee

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Diablo Clinical Research
  • Clinical Research of West Florida
  • Bioclinica Research
  • Altoona Center for Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

KA34 Active Drug

Placebo

Arm Description

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

Placebo is the formulation for KA34.

Outcomes

Primary Outcome Measures

SAD Part: Number of Subjects Who Experienced Treatment Emergent Adverse Events (TEAEs)
TEAEs were collected from time of first administration of IP (Day 1) until 28 days after the last administration of IP. The severity of TEAEs was classified by the investigator as mild, moderate or severe and graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The investigator also assessed relatedness of TEAEs. The number of subjects who experienced any TEAEs, serious TEAEs (SAE), related TEAEs and TEAEs with CTCAE Grade ≥ 3 are presented.
MAD Part: Number of Subjects Who Experienced TEAEs
TEAEs were collected from time of first administration of IP (Day 1) until 30 days after the last administration of IP. The severity of TEAEs was classified by the investigator as mild, moderate or severe and graded using the CTCAE version 5.0. The investigator also assessed relatedness of TEAEs. The number of subjects who experienced any TEAEs, SAEs, related TEAEs and TEAEs with CTCAE Grade ≥ 3 are presented.

Secondary Outcome Measures

SAD Part: Mean Change From Baseline in Hemoglobin at Day 8
The mean changes from baseline at Day 8 in hemoglobin levels for subjects in the SAD part of the study are presented.
MAD Part: Mean Change From Baseline in Hemoglobin at Day 180
The mean changes from baseline at Day 180 in hemoglobin levels for subjects in the MAD part of the study are presented.
SAD Part: Mean Change From Baseline in Hematocrit at Day 8
The mean changes from baseline at Day 8 in hematocrit levels for subjects in the SAD part of the study are presented.
MAD Part: Mean Change From Baseline in Hematocrit at Day 180
The mean changes from baseline at Day 180 in hematocrit levels for subjects in the MAD part of the study are presented.
SAD Part: Mean Change From Baseline in Total Bilirubin and Creatinine at Day 8
The mean changes from baseline at Day 8 in total bilirubin and creatinine for subjects in the SAD part of the study are presented.
MAD Part: Mean Change From Baseline in Total Bilirubin and Creatinine at Day 180
The mean changes from baseline at Day 180 in total bilirubin and creatinine for subjects in the MAD part of the study are presented.
SAD Part: Mean Change From Baseline in Liver Enzymes at Day 8
The mean changes from baseline at Day 8 in the following liver enzyme levels are presented for subjects in the SAD part of the study: alkaline phosphatase (ALP), alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
MAD Part: Mean Change From Baseline in Liver Enzymes at Day 180
The mean changes from baseline at Day 180 in the following liver enzyme levels are presented for subjects in the MAD part of the study: ALP, ALT and AST.
SAD Part: Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Day 8
The mean changes from baseline at Day 8 in systolic blood pressure (SBP) and diastolic blood pressure (DBP) for subjects in the SAD part of the study are presented.
MAD Part: Mean Change From Baseline in SBP and DBP at Day 180
The mean changes from baseline at Day 180 in SBP and DBP for subjects in the MAD part of the study are presented.
SAD Part: Mean Change From Baseline in the QTcF Interval at Day 8
The mean changes from baseline at Day 8 in the electrocardiogram (ECG) parameter QTcF interval for subjects in the SAD part of the study are presented.
MAD Part: Mean Change From Baseline in the QTcF Interval at Day 180
The mean changes from baseline at Day 180 in the ECG parameter QTcF interval for subjects in the MAD part of the study are presented.
SAD Part: Number of Subjects With Injection Site TEAEs
Physical examinations were conducted by a physician or another medically-qualified individual and findings were noted at the injection site during the study. The number of subjects with injection site TEAEs, including the following, are presented: Injection site erythema, Injection site hypersensitivity, Injection site inflammation, Injection site joint discomfort, Injection site joint inflammation, Injection site joint pain, Injection site joint swelling, Injection site nodule, Injection site pain and Injection site swelling.
MAD Part: Number of Subjects With Injection Site TEAEs
Physical examinations were conducted by a physician or another medically-qualified individual and findings were noted at the injection site during the study. The number of subjects with injection site TEAEs, including the following, are presented: Injection site erythema, Injection site hypersensitivity, Injection site inflammation, Injection site joint discomfort, Injection site joint inflammation, Injection site joint pain, Injection site joint swelling, Injection site nodule, Injection site pain and Injection site swelling.
SAD Part: Mean Maximum Plasma Concentration (Cmax)
All Pharmacokinetic (PK) samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. Cmax values were obtained directly from the observed concentration versus time data, and the geometric mean Cmax values for subjects who received KA34 in the SAD part of the study are presented.
MAD Part: Mean Cmax
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. Cmax values were obtained directly from the observed concentration versus time data, and the geometric mean Cmax values for subjects who received KA34 in the MAD part of the study are presented.
SAD Part: Median Time to Maximum Observed Plasma Concentration (Tmax)
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. Tmax was obtained directly from the observed concentration versus time data and the median Tmax values for subjects who received KA34 in the SAD part of the study are presented.
MAD Part: Median Tmax
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. Tmax was obtained directly from the observed concentration versus time data and the median Tmax values for subjects who received KA34 in the MAD part of the study are presented.
SAD Part: Mean Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-t])
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. AUC(0-t) was calculated by linear up/log down trapezoidal summation, and the mean AUC(0-t) values for subjects who received KA34 in the SAD part of the study are presented.
MAD Part: Mean AUC(0-t)
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. AUC(0-t) was calculated by linear up/log down trapezoidal summation, and the mean AUC(0-t) values for subjects who received KA34 in the MAD part of the study are presented.
SAD Part: Mean Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinite Time (AUC[0-inf])
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. AUC(0-inf) was calculated by linear up/log down trapezoidal summation and extrapolated to infinity by the addition of the last quantifiable concentration (Clast) divided by the elimation rate constant (λz), i.e. AUC(0-t) + Clast/λz. The mean AUC(0-inf) values for subjects who received KA34 in the SAD part of the study are presented.
MAD Part: Mean AUC(0-inf)
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. AUC(0-inf) was calculated by linear up/log down trapezoidal summation and extrapolated to infinity by the addition of the last quantifiable concentration (Clast) divided by the elimation rate constant (λz), i.e. AUC(0-t) + Clast/λz. The mean AUC(0-inf) values are presented for subjects who received KA34 in the MAD part of the study.
SAD Part: Mean Apparent Terminal Half-life (t1/2)
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. t1/2 was determined as the natural log of λz, i.e. as ln2/λz. Mean t1/2 values for subjects who received KA34 in the SAD part of the study are presented.
MAD Part: Mean t1/2
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. t1/2 was determined as the natural log of λz, i.e. as ln2/λz. Mean t1/2 values for subjects who received KA34 in the MAD part of the study are presented.
SAD Part: Mean Apparent Clearance (CL/F)
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. The CL/F after extravascular dosing was calculated as dose divided by AUC(0-inf), and is presented for subjects who received KA34 in the SAD part of the study.
MAD Part: Mean CL/F
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. The CL/F after extravascular dosing was calculated as dose divided by AUC(0-inf), and is presented for subjects who received KA34 in the MAD part of the study.
SAD Part: Mean Apparent Volume of Distribution (Vz/F)
The Vz/F was calculated as dose divided by (λz*AUC[0-inf]), and the mean Vz/F values for subjects who received KA34 in the SAD part of the study are presented.
MAD Part: Mean Vz/F
The Vz/F was calculated as dose divided by (λz*AUC[0-inf]), and the mean Vz/F values for subjects who received KA34 in the MAD part of the study are presented.

Full Information

First Posted
April 20, 2017
Last Updated
December 22, 2022
Sponsor
Calibr, a division of Scripps Research
Collaborators
California Institute for Regenerative Medicine (CIRM)
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1. Study Identification

Unique Protocol Identification Number
NCT03133676
Brief Title
A Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of KA34 in Subjects With Knee Osteoarthritis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 2, 2018 (Actual)
Primary Completion Date
April 28, 2020 (Actual)
Study Completion Date
April 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Calibr, a division of Scripps Research
Collaborators
California Institute for Regenerative Medicine (CIRM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Osteoarthritis, Arthritis, Joint Disease, Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KA34 Active Drug
Arm Type
Experimental
Arm Description
KA34 active drug in the dose range of 50 - 400 ug per knee
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo is the formulation for KA34.
Intervention Type
Drug
Intervention Name(s)
KA34
Other Intervention Name(s)
KA-34
Intervention Description
50 µg - 400 µg intra-articular injection (single or multiple doses)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
50 µg - 400 µg intra-articular injection (single or multiple doses)
Primary Outcome Measure Information:
Title
SAD Part: Number of Subjects Who Experienced Treatment Emergent Adverse Events (TEAEs)
Description
TEAEs were collected from time of first administration of IP (Day 1) until 28 days after the last administration of IP. The severity of TEAEs was classified by the investigator as mild, moderate or severe and graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The investigator also assessed relatedness of TEAEs. The number of subjects who experienced any TEAEs, serious TEAEs (SAE), related TEAEs and TEAEs with CTCAE Grade ≥ 3 are presented.
Time Frame
Day 1 up to Day 29
Title
MAD Part: Number of Subjects Who Experienced TEAEs
Description
TEAEs were collected from time of first administration of IP (Day 1) until 30 days after the last administration of IP. The severity of TEAEs was classified by the investigator as mild, moderate or severe and graded using the CTCAE version 5.0. The investigator also assessed relatedness of TEAEs. The number of subjects who experienced any TEAEs, SAEs, related TEAEs and TEAEs with CTCAE Grade ≥ 3 are presented.
Time Frame
Day 1 up to Day 180
Secondary Outcome Measure Information:
Title
SAD Part: Mean Change From Baseline in Hemoglobin at Day 8
Description
The mean changes from baseline at Day 8 in hemoglobin levels for subjects in the SAD part of the study are presented.
Time Frame
Baseline and Day 8
Title
MAD Part: Mean Change From Baseline in Hemoglobin at Day 180
Description
The mean changes from baseline at Day 180 in hemoglobin levels for subjects in the MAD part of the study are presented.
Time Frame
Baseline and Day 180
Title
SAD Part: Mean Change From Baseline in Hematocrit at Day 8
Description
The mean changes from baseline at Day 8 in hematocrit levels for subjects in the SAD part of the study are presented.
Time Frame
Baseline and Day 8
Title
MAD Part: Mean Change From Baseline in Hematocrit at Day 180
Description
The mean changes from baseline at Day 180 in hematocrit levels for subjects in the MAD part of the study are presented.
Time Frame
Baseline and Day 180
Title
SAD Part: Mean Change From Baseline in Total Bilirubin and Creatinine at Day 8
Description
The mean changes from baseline at Day 8 in total bilirubin and creatinine for subjects in the SAD part of the study are presented.
Time Frame
Baseline and Day 8
Title
MAD Part: Mean Change From Baseline in Total Bilirubin and Creatinine at Day 180
Description
The mean changes from baseline at Day 180 in total bilirubin and creatinine for subjects in the MAD part of the study are presented.
Time Frame
Baseline and Day 180
Title
SAD Part: Mean Change From Baseline in Liver Enzymes at Day 8
Description
The mean changes from baseline at Day 8 in the following liver enzyme levels are presented for subjects in the SAD part of the study: alkaline phosphatase (ALP), alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
Time Frame
Baseline and Day 8
Title
MAD Part: Mean Change From Baseline in Liver Enzymes at Day 180
Description
The mean changes from baseline at Day 180 in the following liver enzyme levels are presented for subjects in the MAD part of the study: ALP, ALT and AST.
Time Frame
Baseline and Day 180
Title
SAD Part: Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Day 8
Description
The mean changes from baseline at Day 8 in systolic blood pressure (SBP) and diastolic blood pressure (DBP) for subjects in the SAD part of the study are presented.
Time Frame
Baseline and Day 8
Title
MAD Part: Mean Change From Baseline in SBP and DBP at Day 180
Description
The mean changes from baseline at Day 180 in SBP and DBP for subjects in the MAD part of the study are presented.
Time Frame
Baseline and Day 180
Title
SAD Part: Mean Change From Baseline in the QTcF Interval at Day 8
Description
The mean changes from baseline at Day 8 in the electrocardiogram (ECG) parameter QTcF interval for subjects in the SAD part of the study are presented.
Time Frame
Baseline and Day 8
Title
MAD Part: Mean Change From Baseline in the QTcF Interval at Day 180
Description
The mean changes from baseline at Day 180 in the ECG parameter QTcF interval for subjects in the MAD part of the study are presented.
Time Frame
Baseline and Day 180
Title
SAD Part: Number of Subjects With Injection Site TEAEs
Description
Physical examinations were conducted by a physician or another medically-qualified individual and findings were noted at the injection site during the study. The number of subjects with injection site TEAEs, including the following, are presented: Injection site erythema, Injection site hypersensitivity, Injection site inflammation, Injection site joint discomfort, Injection site joint inflammation, Injection site joint pain, Injection site joint swelling, Injection site nodule, Injection site pain and Injection site swelling.
Time Frame
Baseline up to Day 29
Title
MAD Part: Number of Subjects With Injection Site TEAEs
Description
Physical examinations were conducted by a physician or another medically-qualified individual and findings were noted at the injection site during the study. The number of subjects with injection site TEAEs, including the following, are presented: Injection site erythema, Injection site hypersensitivity, Injection site inflammation, Injection site joint discomfort, Injection site joint inflammation, Injection site joint pain, Injection site joint swelling, Injection site nodule, Injection site pain and Injection site swelling.
Time Frame
Baseline up to Day 180
Title
SAD Part: Mean Maximum Plasma Concentration (Cmax)
Description
All Pharmacokinetic (PK) samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. Cmax values were obtained directly from the observed concentration versus time data, and the geometric mean Cmax values for subjects who received KA34 in the SAD part of the study are presented.
Time Frame
Pre-dose up to 4 hours post-dose on Day 1
Title
MAD Part: Mean Cmax
Description
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. Cmax values were obtained directly from the observed concentration versus time data, and the geometric mean Cmax values for subjects who received KA34 in the MAD part of the study are presented.
Time Frame
Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29
Title
SAD Part: Median Time to Maximum Observed Plasma Concentration (Tmax)
Description
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. Tmax was obtained directly from the observed concentration versus time data and the median Tmax values for subjects who received KA34 in the SAD part of the study are presented.
Time Frame
Pre-dose up to 4 hours post-dose on Day 1
Title
MAD Part: Median Tmax
Description
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. Tmax was obtained directly from the observed concentration versus time data and the median Tmax values for subjects who received KA34 in the MAD part of the study are presented.
Time Frame
Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29
Title
SAD Part: Mean Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-t])
Description
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. AUC(0-t) was calculated by linear up/log down trapezoidal summation, and the mean AUC(0-t) values for subjects who received KA34 in the SAD part of the study are presented.
Time Frame
Pre-dose up to 4 hours post-dose on Day 1
Title
MAD Part: Mean AUC(0-t)
Description
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. AUC(0-t) was calculated by linear up/log down trapezoidal summation, and the mean AUC(0-t) values for subjects who received KA34 in the MAD part of the study are presented.
Time Frame
Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29
Title
SAD Part: Mean Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinite Time (AUC[0-inf])
Description
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. AUC(0-inf) was calculated by linear up/log down trapezoidal summation and extrapolated to infinity by the addition of the last quantifiable concentration (Clast) divided by the elimation rate constant (λz), i.e. AUC(0-t) + Clast/λz. The mean AUC(0-inf) values for subjects who received KA34 in the SAD part of the study are presented.
Time Frame
Pre-dose up to 4 hours post-dose on Day 1
Title
MAD Part: Mean AUC(0-inf)
Description
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. AUC(0-inf) was calculated by linear up/log down trapezoidal summation and extrapolated to infinity by the addition of the last quantifiable concentration (Clast) divided by the elimation rate constant (λz), i.e. AUC(0-t) + Clast/λz. The mean AUC(0-inf) values are presented for subjects who received KA34 in the MAD part of the study.
Time Frame
Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29
Title
SAD Part: Mean Apparent Terminal Half-life (t1/2)
Description
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. t1/2 was determined as the natural log of λz, i.e. as ln2/λz. Mean t1/2 values for subjects who received KA34 in the SAD part of the study are presented.
Time Frame
Pre-dose up to 4 hours post-dose on Day 1
Title
MAD Part: Mean t1/2
Description
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. t1/2 was determined as the natural log of λz, i.e. as ln2/λz. Mean t1/2 values for subjects who received KA34 in the MAD part of the study are presented.
Time Frame
Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29
Title
SAD Part: Mean Apparent Clearance (CL/F)
Description
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. The CL/F after extravascular dosing was calculated as dose divided by AUC(0-inf), and is presented for subjects who received KA34 in the SAD part of the study.
Time Frame
Pre-dose up to 4 hours post-dose on Day 1
Title
MAD Part: Mean CL/F
Description
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. The CL/F after extravascular dosing was calculated as dose divided by AUC(0-inf), and is presented for subjects who received KA34 in the MAD part of the study.
Time Frame
Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29
Title
SAD Part: Mean Apparent Volume of Distribution (Vz/F)
Description
The Vz/F was calculated as dose divided by (λz*AUC[0-inf]), and the mean Vz/F values for subjects who received KA34 in the SAD part of the study are presented.
Time Frame
Pre-dose up to 4 hours post-dose on Day 1
Title
MAD Part: Mean Vz/F
Description
The Vz/F was calculated as dose divided by (λz*AUC[0-inf]), and the mean Vz/F values for subjects who received KA34 in the MAD part of the study are presented.
Time Frame
Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Lotz, MD
Organizational Affiliation
Calibr, a division of Scripps Research
Official's Role
Study Director
Facility Information:
Facility Name
Diablo Clinical Research
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Clinical Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Bioclinica Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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