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

NCT04670289 | Completed Phase 1

• 1 other identifier: CWT-TE1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tennis Elbow

Outcome Measures

Primary Outcomes (5)

• Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of clinical laboratory abnormalities between TenoMiR versus placebo.

  Comparison of clinical laboratory abnormalities between TenoMiR versus placebo as measured by blood chemistry, haematology, coagulation, serology and urinalysis.

  14 days

• Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of changes in vital signs between TenoMiR versus placebo.

  Comparison of changes in vital signs between TenoMiR versus placebo as measured by supine vital signs including pulse rate, blood pressure, respiration rate and oral temperature.

  14 days

• Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of changes in 12 lead ECG parameters between TenoMiR versus placebo.

  Comparison of changes in 12 lead ECG parameters as measured by Heart Rate and PR, RR, QRS, QT and QT intervals.

  14 days

• Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of physical examination between TenoMiR versus placebo.

  Comparison of changes in physical examination between TenoMiR versus placebo as measured by height, BMI, and body weight, and assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular system, abdomen (liver and spleen), lymph nodes and extremities.

  14 days

• Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of skin score assessment between TenoMiR versus placebo.

  Comparison of changes in skin score assessment of injection site between TenoMiR versus placebo as measured by for erythema, pain, tenderness and swelling.

  14 days

Secondary Outcomes (8)

• Single dose pharmacokinetics (PK) of TenoMiR administration in subjects with lateral epicondylitis (Cmax).

  90 days

• Single dose pharmacokinetics (PK) of TenoMiR administration in subjects with lateral epicondylitis (tmax).

  90 days

• Single dose pharmacokinetics (PK) of TenoMiR administration in subjects with lateral epicondylitis (AUC).

  90 days

• Visual Analogue Score (VAS) pain score

  90 days

• Disabilities of the Arm, Shoulder, and Hand (Quick DASH) score

  90 days

Study Arms (2)

Treatment

EXPERIMENTAL

TenoMiR intralesional injection

Drug: TenoMiR (Low Dose); Drug: TenoMiR (Medium Dose); Drug: TenoMiR (High Dose)

Placebo

PLACEBO COMPARATOR

0.9% saline intralesional injection

Drug: Placebo

Interventions

TenoMiR (Low Dose) DRUG

Mimic of miR29a

Also known as: CWT-001

Treatment

TenoMiR (Medium Dose) DRUG

Mimic of miR29a

Also known as: CWT-001

Treatment

TenoMiR (High Dose) DRUG

Mimic of miR29a

Also known as: CWT-001

Treatment

Placebo DRUG

0.9% saline

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has a clinical diagnosis of lateral epicondylitis.
• 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.
• 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).
• Subject's symptoms have persisted for at least 6 weeks to 6 months, despite conservative treatment that includes 1 or combinations of:
• Physical therapy
• Splinting
• NSAIDs

You may not qualify if:

• Subjects with any of the following will be excluded from study participation:
• Subject has undergone previous corticosteroid injection therapy to the affected elbow in less than 6 months prior to enrolment.
• 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.
• Subject has received previous Platelet-Rich Plasma (PRP) injection to the affected elbow.
• Subject uses or has recent use of medications known to affect the skeleton (e.g., glucocorticoid usage \>5 mg/day, fluoroquinolone antibiotics).
• Subject has undergone surgical intervention to the affected elbow for the treatment of lateral epicondylitis.

Sponsors & Collaborators

• Causeway Therapeutics: lead

Study Sites (1)

MAC Clinical Research

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, Controlled, Randomised, Double Blind, Single Centre Trial

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 17, 2020
• Study Start: August 14, 2020
• Primary Completion: May 19, 2021
• Study Completion: August 18, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-09

Locations

GB (1)