NCT03133676

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Calibr, a division of Scripps Research · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	KA34	50 µg - 400 µg intra-articular injection (single or multiple doses)
DRUG	Placebo	50 µg - 400 µg intra-articular injection (single or multiple doses)

Timeline

• Start date: 2018-05-02
• Primary completion: 2020-04-28
• Completion: 2020-04-28
• First posted: 2017-04-28
• Last updated: 2022-12-27
• Results posted: 2021-05-17

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study