At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 60 enrolled
Drug / intervention
KA34 +1 moredrug
Likely dose
KA34 50–400 µg intra-articular injectionAI-extracted
Key inclusion· 1
- ✓Diagnosis of localized osteoarthritis of the knee
Key exclusion· 4
- ✕BMI greater than 40
- ✕Grade 0, 3, or 4 osteoarthritis on Kellgren-Lawrence classification (i.e., must be Grade 1 or 2)
- ✕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
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating KA34 and Placebo for Osteoarthritis, Knee. Completed, enrolled 60 participants across 4 sites.
Detailed Summary
This study will evaluate the safety and tolerability of KA34 when administered via intra-articular injection to subjects with osteoarthritis of the knee.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Knee
CountriesUnited States
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartMay 2018
Primary CompletionApr 2020
TodayJul 2026
First PostedApr 28, 2017
Enrollment StartMay 2, 2018
Primary CompletionApr 28, 2020
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 9.2 years ago
Interventions
KA34drug
50 µg - 400 µg intra-articular injection (single or multiple doses)
Placebodrug
50 µg - 400 µg intra-articular injection (single or multiple doses)