Safety, Tolerability, and Pharmacokinetics of single dose TenoMiR
Research type
Research Study
Full title
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 Investigational Medicinal Product: TenoMiR
IRAS ID
266550
Contact name
Pui Man Leung
Contact email
Sponsor organisation
Causeway Therapeutics
Eudract number
2019-001012-30
Duration of Study in the UK
0 years, 7 months, 14 days
Research summary
Summary of Research\nSafety, Tolerability, and Pharmacokinetics of single dose TenoMiR in patients with tennis elbow (lateral epicondilytis)\n\nThis study is testing a drug called TenoMiR (the ‘study drug’) 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. \nThe study will assess the safety and tolerability of the study drug and see how the body absorbs and removes the study drug. The study will also assess the effect of the study drug on the body. This is the first time the study drug has been tested in humans, but has undergone testing on animals. Up to 32 participants may join the study and up to 24 of these will receive the study drug.\nParticipants will need to come to the clinic for 9 outpatient visits over approximately 4 months. On one of these days, participants will receive 1 dose of study drug or 1 dose of placebo by injection into the elbow. Neither the study doctor nor the participant will know if they receive the study drug or placebo, it is randomly determined by chance. Up to four different doses of the drug will be tested. The research is funded by the Sponsor, Causeway Therapeutics.\n\nSummary of Results\nSingle injections of TenoMiR appeared to be well tolerated over the 200 to 1500 μg/mL dose range, and there were no safety concerns that could be attributed to treatment with TenoMiR. No deaths were reported during the study and one serious adverse event (SAE) was reported, a suspected SARS-CoV-2 infection that required hospitalisation in the 200 μg/mL TenoMiR treatment group. No subjects discontinued due to a treatment-emergent adverse event (TEAE).\nThere were no significant treatment- or dose-related trends in clinical laboratory evaluations, vital signs or ECG parameters. Four clinically significant physical examination findings were reported by 2 subjects but were not considered to be related to treatment.\nBetween-subject variability in the extent of systemic exposure to miR29a was considered to be moderate to high.\nFor the majority of efficacy parameters, decreases from baseline were observed for all active treatment groups and all placebo groups at all the assessed post-injection timepoints.\nThere were no apparent TenoMiR dose-related trends in the decreases from baseline for the active groups for any efficacy parameter.\nStatistically significant improvements in tendon structure at Days 28 and 90 post-treatment with all dosages of TenoMiR.\n
REC name
Wales REC 1
REC reference
19/WA/0300
Date of REC Opinion
5 Nov 2019
REC opinion
Further Information Favourable Opinion