Trials / Completed

CompletedNCT04670289

Safety, Tolerability, and Pharmacokinetics of Single Dose TenoMiR as a Treatment for Tennis Elbow

A Phase 1, Single-Centre, Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of TenoMiR Injections in Subjects With Lateral Epicondylitis

Status: Completed
Phase: Phase 1
Study type: Interventional
Enrollment: 24 (actual)

Sponsor: Causeway Therapeutics · Industry
Sex: All
Age: 18 Years – 70 Years
Healthy volunteers: Not accepted

Summary

This study is testing a drug called TenoMiR that is being developed for the treatment of tennis elbow (lateral epicondylitis). The study drug is a new compound that works by improving the quality of the collagen which helps repair damage to the elbow. The study drug is being developed in the hope of providing a more reliable treatment than those currently available and can be given at the time of first diagnosis, so that recovery can begin as soon as possible.

Detailed description

TenoMiR a chemically synthesised mimic of microRNA-29a (miR29a) which has improved stability, activity and cellular uptake while being non-immunogenic, has been created to restore miR29a levels back to pre-injury levels. TenoMiR is unique in directly targeting the key changes in collagen production associated with tendinopathy. Unlike other therapies, TenoMiR has a well-defined mode-of-action that is supported by a wealth of scientific data. Moreover, treatment with TenoMiR does not require invasive biopsies and can be delivered at the point of initial diagnosis initiating recovery at the very earliest time.

Conditions

Tennis Elbow

Interventions

Type	Name	Description
DRUG	TenoMiR (Low Dose)	Mimic of miR29a
DRUG	TenoMiR (Medium Dose)	Mimic of miR29a
DRUG	TenoMiR (High Dose)	Mimic of miR29a
DRUG	Placebo	0.9% saline

Timeline

Start date: 2020-08-14
Primary completion: 2021-05-19
Completion: 2021-08-18
First posted: 2020-12-17
Last updated: 2021-09-17

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT04670289. Inclusion in this directory is not an endorsement.