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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-14

Study Completion Date

2021-08-18

Brief Summary

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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.

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Detailed Description

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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

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Tennis Elbow

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, Controlled, Randomised, Double Blind, Single Centre Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment

TenoMiR intralesional injection

Group Type EXPERIMENTAL

TenoMiR (Low Dose)

Intervention Type DRUG

Mimic of miR29a

TenoMiR (Medium Dose)

Intervention Type DRUG

Mimic of miR29a

TenoMiR (High Dose)

Intervention Type DRUG

Mimic of miR29a

Placebo

0.9% saline intralesional injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0.9% saline

Interventions

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TenoMiR (Low Dose)

Mimic of miR29a

Intervention Type DRUG

TenoMiR (Medium Dose)

Mimic of miR29a

Intervention Type DRUG

TenoMiR (High Dose)

Mimic of miR29a

Intervention Type DRUG

Placebo

0.9% saline

Intervention Type DRUG

Other Intervention Names

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CWT-001 CWT-001 CWT-001

Eligibility Criteria

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Inclusion Criteria

1. Subject has a clinical diagnosis of lateral epicondylitis.
2. Aside from lateral epicondylitis, the subject is otherwise healthy as determined by a responsible physician, based on medical history, physical examinations, concomitant medication, vital signs, 12-lead ECGs and clinical laboratory evaluations. Laboratory values may be re-tested once at the discretion of the Investigator.
3. Subject's symptoms can be reproduced with resisted supination or wrist dorsiflexion (as confirmed by tenderness at lateral epicondyle and positive pick up back of chair sign).
4. Subject's symptoms have persisted for at least 6 weeks to 6 months, despite conservative treatment that includes 1 or combinations of:

1. Physical therapy
2. Splinting
3. NSAIDs

Exclusion Criteria

Subjects with any of the following will be excluded from study participation:

1. Subject has undergone previous corticosteroid injection therapy to the affected elbow in less than 6 months prior to enrolment.
2. Subjects unwilling or unable to discontinue use of pain medication (opiate or NSAID) from at least 1 week prior to Investigational Medicinal Product (IMP) administration.
3. Subject has received previous Platelet-Rich Plasma (PRP) injection to the affected elbow.
4. Subject uses or has recent use of medications known to affect the skeleton (e.g., glucocorticoid usage \>5 mg/day, fluoroquinolone antibiotics).
5. Subject has undergone surgical intervention to the affected elbow for the treatment of lateral epicondylitis.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No