NCT06989645

A Phase 1/2a Study to Evaluate Single Intraarticular Injections of 3 Dose Levels of SYN321 and Placebo in Patients With Symptomatic Knee Osteoarthritis

A Prospective, Double-blinded, Randomized, Placebo-controlled Phase 1/2a Study to Assess Safety, Tolerability, Systemic Exposure, and Preliminary Efficacy of Single Intraarticular Injections of 3 Dose Levels of SYN321 and Placebo in Patients With Symptomatic Knee Osteoarthritis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Synartro AB · Industry
• Sex: All
• Age: 40 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

This is a, phase 1/2a trial, to assess the safety, tolerability, systemic exposure as well as preliminary efficacy following a single intra-articular injection of 3 dose levels of SYN321 in patients with symptomatic knee osteoarthritis (KOA).

Detailed description

Participants will receive a single intra-articular injection of SYN321 or placebo. 4 sequential cohorts are planned. The fourth cohort will repeat one of the previously 3 administered dose levels. The first 2 participants in each cohort will be dosed in a sentinel fashion. The participants will be followed for 56 days.

Conditions

• Osteoarthritis of Knee

Interventions

Type	Name	Description
DRUG	SYN321	Intra-articular
DRUG	Placebo	Intra-articular

Timeline

• Start date: 2025-08-19
• Primary completion: 2026-02-02
• Completion: 2026-03-02
• First posted: 2025-05-25
• Last updated: 2026-03-06

Locations

1 site across 1 country: Sweden