Phase 1
Completed N=60
A Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of KA34 in Subjects With Knee Osteoarthritis
Osteoarthritis, Knee
Source: ClinicalTrials.gov NCT03133676 ↗
Enrolled (actual)
60
Serious AEs
1.7%
Results posted
May 2021
Primary outcomePrimary: SAD Part: Number of Subjects Who Experienced Treatment Emergent Adverse Events (TEAEs) — 1; 2; 1; 4 Participants
Summary
This study will evaluate the safety and tolerability of KA34 when administered via intra-articular injection to subjects with osteoarthritis of the knee.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SAD Part: Number of Subjects Who Experienced Treatment Emergent Adverse Events (TEAEs) |
1; 2; 1; 4; 1; 0 | — |
| PRIMARY MAD Part: Number of Subjects Who Experienced TEAEs |
7; 3; 6; 5; 4; 1 | — |
| SECONDARY SAD Part: Mean Change From Baseline in Hemoglobin at Day 8 |
-0.12; 0.77; -0.07; 0.08; -0.32 | — |
| SECONDARY MAD Part: Mean Change From Baseline in Hemoglobin at Day 180 |
0.36; -0.60; -0.48; -0.07 | — |
| SECONDARY SAD Part: Mean Change From Baseline in Hematocrit at Day 8 |
-0.20; 2.40; -0.37; 0.12; -0.97 | — |
| SECONDARY MAD Part: Mean Change From Baseline in Hematocrit at Day 180 |
42.68; 41.33; 42.12; 44.54 | — |
| SECONDARY SAD Part: Mean Change From Baseline in Total Bilirubin and Creatinine at Day 8 |
0.023; 0.053; -0.033; 0.100; 0.037; -0.038 | — |
| SECONDARY MAD Part: Mean Change From Baseline in Total Bilirubin and Creatinine at Day 180 |
0.067; -0.051; -0.017; -0.043; -0.038; -0.006 | — |
| SECONDARY SAD Part: Mean Change From Baseline in Liver Enzymes at Day 8 |
0.0; -7.7; 3.7; 0.0; 4.0; 0.8 | — |
| SECONDARY MAD Part: Mean Change From Baseline in Liver Enzymes at Day 180 |
-3.4; -0.2; -10.2; 1.1; 2.1; -6.6 | — |
| SECONDARY SAD Part: Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Day 8 |
-7.3; 6.0; -11.3; 7.8; 3.7; -2.0 | — |
| SECONDARY MAD Part: Mean Change From Baseline in SBP and DBP at Day 180 |
7.7; 8.9; -2.1; -0.3; 6.6; 1.7 | — |
| SECONDARY SAD Part: Mean Change From Baseline in the QTcF Interval at Day 8 |
2.3; 11.7; -3.7; -10.7; 3.5 | — |
| SECONDARY MAD Part: Mean Change From Baseline in the QTcF Interval at Day 180 |
3.9; 1.9; -3.6; 3.4 | — |
| SECONDARY SAD Part: Number of Subjects With Injection Site TEAEs |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY MAD Part: Number of Subjects With Injection Site TEAEs |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY SAD Part: Mean Maximum Plasma Concentration (Cmax) |
0.8528; 2.757; 5.732; 9.435 | — |
| SECONDARY MAD Part: Mean Cmax |
2.536; 4.807; 10.67 | — |
| SECONDARY SAD Part: Median Time to Maximum Observed Plasma Concentration (Tmax) |
0.25; 0.50; 0.38; 0.30 | — |
| SECONDARY MAD Part: Median Tmax |
0.50; 0.30; 0.50 | — |
| SECONDARY SAD Part: Mean Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-t]) |
1.430; 4.473; 9.933; 15.73 | — |
| SECONDARY MAD Part: Mean AUC(0-t) |
4.578; 7.077; 19.53 | — |
| SECONDARY SAD Part: Mean Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinite Time (AUC[0-inf]) |
1.595; 5.425; 11.09; 17.34 | — |
| SECONDARY MAD Part: Mean AUC(0-inf) |
5.041; 7.370; 21.22 | — |
| SECONDARY SAD Part: Mean Apparent Terminal Half-life (t1/2) |
1.253; 1.420; 1.145; 1.222 | — |
| SECONDARY MAD Part: Mean t1/2 |
1.072; 0.9997; 0.9286 | — |
| SECONDARY SAD Part: Mean Apparent Clearance (CL/F) |
31.70; 25.10; 19.22; 23.92 | — |
| SECONDARY MAD Part: Mean CL/F |
21.43; 28.11; 23.85 | — |
| SECONDARY SAD Part: Mean Apparent Volume of Distribution (Vz/F) |
38.25; 34.30; 31.47; 35.56 | — |
| SECONDARY MAD Part: Mean Vz/F |
32.51; 37.98; 30.00 | — |
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
Data sourced from ClinicalTrials.gov (NCT03133676). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.