JUV-161 given to healthy adults during one-leg immobilization

Double-blind, Placebo-controlled, Randomized, Safety and Efficacy Study of JUV-161 Administered to Healthy Volunteers Undergoing Unilateral Lower Limb Immobilization (ULLI)

This study will test whether weekly injections of JUV-161 can reduce muscle loss in healthy adults aged 40–65 who have one lower limb immobilized.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 45 Years to 65 Years
• Sex: All
• Sponsor: Juvena Therapeutics (Industry-sponsored)
• Locations: 2 sites (Auckland and 1 other locations)
• Trial ID: NCT07397468 on ClinicalTrials.gov

What this trial studies

This is a double-blind, placebo-controlled, randomized Phase 1/2 study in up to 40 healthy volunteers in New Zealand using unilateral lower limb immobilization (ULLI) to model disuse atrophy. Participants aged 40–65 will be randomized to one of two weekly subcutaneous doses of JUV-161 or matching placebo for about six weeks, within a 96-day total study period. Outcomes include safety measures, muscle mass and strength endpoints, and tissue biomarkers collected by muscle biopsy. The design isolates disuse-related muscle loss to test whether JUV-161’s muscle-growth signaling can prevent or reduce atrophy during immobilization.

Who should consider this trial

Good fit: Ideal candidates are healthy, ambulatory males or post-menopausal females aged 40–65 with BMI ≤30 who can comply with one-leg immobilization, clinic visits, and a muscle biopsy and who are not using anabolic steroids or frequent resistance training.

Not a fit: People with active muscle-wasting diseases, recent anabolic steroid use, regular resistance training (>1×/week), those outside the age or BMI ranges, non-ambulatory individuals, or those unwilling to undergo immobilization or biopsy are unlikely to be appropriate or to benefit.

Why it matters

Potential benefit: If successful, JUV-161 could help prevent or lessen muscle loss during periods of immobilization, preserving strength and function.

How similar studies have performed: Other early-phase programs targeting muscle-growth pathways and studies using limb suspension/immobilization have shown mixed but sometimes promising early signals, so this approach is not entirely novel but remains under active investigation.

Eligibility criteria

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.

Where this trial is running

Auckland and 1 other locations

• New Zealand Clinical Research — Auckland, New Zealand (Recruiting)
• New Zealand Clinical Research — Christchurch, New Zealand (Recruiting)

Study contacts

• Principal investigator: Chris Brett, MD — Nzcr
• Study coordinator: Chris Brett, MD

Conditions Healthy Volunteers