Can a shot stop muscles from shrinking when your leg is in a cast?
NCT ID NCT07397468
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests an experimental drug called JUV-161 in healthy volunteers aged 40 to 65 who will have one leg immobilized for several weeks. The goal is to see if the drug can prevent muscle wasting (atrophy) and is safe. Participants receive weekly injections of either JUV-161 or a placebo for about 6 weeks, with muscle changes tracked by MRI and blood tests.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- JUV-161 (an experimental drug injected under the skin)
- What this could lead to
- If it works, this could point toward a treatment to prevent muscle wasting in people who are temporarily unable to move a limb.
- What could go wrong
- This is an early-phase trial with only 36 healthy volunteers, so results may not apply to patients. The drug's safety and effectiveness are still unproven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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45 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Males or post-menopausal females aged ≥40 years of age and ≤65 years of age at time of informed consent. Post-menopausal is defined as no menses for at least 12 months without an alternative medical cause and a Screening follicle stimulating hormone (FSH) level \>40 U/L. 2. Willing and able to give informed consent and comply with the requirements of the protocol, including muscle biopsy. 3. Are healthy in the opinion of the Investigator, based on physical examination, medical history, clinical laboratory tests, vital signs, and resting electrocardiogram. 4. BMI ≤ 30 kg/m2 5. Ambulatory (N.B.: The study may not suitable for subjects who need to drive or have dependents who require them to be fully mobile or difficult access to home or work.) Exclusion Criteria: 1. Any anabolic steroid use or any condition that might affect muscle mass or strength 2. Participation in resistance or strength training at a frequency \>1 time/week within 30-days prior to screening 3. Weight-loss diet within 30-days prior to screening or actively pursuing weight loss, or intending to actively pursue weight loss diet or activities during the study. 4. Use of dietary supplements e.g. protein supplements, amino-acid supplements within 30 days prior to Screening: use of protein supplements within 4 weeks prior to randomization; use of omega-3 supplements within 3 months prior to Screening. 5. History of alcohol misuse (males: ≥14 standard drinks/week, females ≥7 standard drinks/week) or drug misuse (current or past-12-month substance use disorder per DSM-5 and/or ICD criteria). 6. Have an active malignancy or have a history of malignancy within 5 years prior to Screening. (Subjects with prior basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that were successfully treated may be included.) 7. Have any of the following known active infections: 1. Infection requiring systemic antiviral or antimicrobial therapy that will not be completed within 30 days prior to screening 2. Known history of, or positive Screening serology test result for, any of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV). 8. Have any clinical history or other active medical condition, psychiatric disorder or clinically significant laboratory abnormality, vital sign, ECG abnormality or other finding that, in the investigator's opinion, is likely to increase the risk of study participation, confound study results, interfere with study conduct, or otherwise risk non-compliance with study requirements. 9. Implanted electronic device e.g. pace-maker, ICD, nerve stimulator, infusion pump. 10. Have any of the following: 1. History of diabetes, thyroid disease, liver disease, coronary artery disease, peripheral vascular disease or risk factors for peripheral vascular disease (e.g., uncontrolled hypertension, obesity, diabetes, hypercholesterolemia \> 6.5 mmol/L (250 mg/dl), claudication or evidence of venous or arterial insufficiency upon palpitation of femoral, popliteal and pedal arteries) 2. History of bleeding disorder or excessive bleeding 3. At risk for, or previous history of deep vein thrombosis (DVT) (including family history) 4. History of pulmonary emboli 5. History of myeloproliferative disease including polycythemia vera (Hb \>16.5 g/dL for males or \>16.0 g/dL for females and/or hematocrit \>49% for males or \>48% for females) or thrombocytosis (platelet count \>400 x109/L) 6. History of connective tissue diseases (positive lupus anticoagulant), hyperhomocysteinemia, deficiencies of factor V Leiden, proteins S and C, and antithrombin III 7. Impaired renal function (estimated glomerular filtration rate \[eGFR\] \<60ml/min/1.73m2, using the CKD-EPI (2021) equation) 8. Platelet count \< 125 X 109/L 9. Use of anticoagulants or INR \> ULN 10. Electrocardiogram (ECG) showing QTcF \> 470 msec female or \> 450 msec male 11. Have received treatment with any prescription medication or treatment with any non-prescription medication within 14 days prior to screening (exception: acetaminophen up to 2 g per day prior to dosing is permitted) The use of statins, steroids or non-steroidal anti-inflammatory agents is specifically prohibited. 12. Any vaccination (therapeutic or prophylactic) within 30 days prior to screening and/or plans to receive any vaccination during the course of the study. 13. Prior exposure to JUV-161 or have known allergies to any components of the JUV-161 formulation. 14. History of immune reaction to any biologic therapy. 15. Donation or loss of greater than 1 unit (450 mL) of blood or donation of plasma through plasmapheresis within 30 days prior to screening. 16. Pregnant, breast-feeding, or is a woman of child-bearing potential (defined as fertile and following menarche until becoming post menopausal) or is not confirmed as post-menopausal at screening. 17. Use of hormone therapy e.g. estrogen within 60 days before Screening. 18. Recent (within 3 months of screening) history of surgery or significant trauma. 19. Active smoker or history of smoking/ nicotine use within the last 5 years before screening, and/or unwilling to abstain from tobacco/nicotine use during the study.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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New Zealand Clinical Research
RECRUITINGAuckland, 1010, New Zealand
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New Zealand Clinical Research
RECRUITINGChristchurch, 8011, New Zealand
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