Actively Recruiting
To studyJUV-161 Administered to Healthy Volunteers Undergoing Unilateral Lower Limb Immobilization (ULLI)
Led by Juvena Therapeutics · Updated on 2026-04-20
36
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a double-blind, placebo-controlled, randomized study of 96 days total duration to assess the effect of JUV-161 on muscle disuse atrophy. This will be a multicenter study in New Zealand and will include up to 40 healthy volunteers aged between 40 to 65 years of age. Following the screening period, subjects will be randomized to receive either weekly subcutaneous (SC) injections of one of two doses of JUV-161 or matching placebo for a period of approximately 6 weeks.
CONDITIONS
Official Title
To studyJUV-161 Administered to Healthy Volunteers Undergoing Unilateral Lower Limb Immobilization (ULLI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or post-menopausal females aged 40 to 65 years at time of consent
- Able and willing to give informed consent and comply with study requirements including muscle biopsy
- Healthy based on physical exam, medical history, lab tests, vital signs, and ECG
- Body Mass Index (BMI) of 30 kg/m2 or less
- Able to walk independently (ambulatory)
You will not qualify if you...
- Use of anabolic steroids or any condition affecting muscle mass or strength
- Resistance or strength training more than once per week within 30 days before screening
- Weight-loss diet within 30 days before screening or plans to pursue weight loss during the study
- Use of dietary supplements like protein or omega-3 within specified periods before screening
- History of alcohol misuse or drug misuse in the past year
- Active malignancy or history of malignancy within 5 years (except certain skin or cervical cancers)
- Active infections requiring treatment or positive tests for HIV, Hepatitis B or C
- Medical or psychiatric conditions, lab abnormalities, or implanted electronic devices that increase risk or interfere with study
- History of diabetes, thyroid, liver, heart or vascular diseases, bleeding disorders, clotting risks
- Impaired kidney function or abnormal platelet count
- Use of anticoagulants or abnormal ECG results
- Recent use of prescription or non-prescription medications (except acetaminophen)
- Vaccination within 30 days before screening or planned during study
- Prior exposure or allergy to JUV-161 components
- History of immune reaction to biologic therapy
- Recent blood donation or significant blood loss
- Pregnant, breastfeeding, or women not confirmed post-menopausal
- Use of hormone therapy within 60 days before screening
- Recent surgery or significant trauma within 3 months
- Active smoker or nicotine use within last 5 years and unwilling to abstain during study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
New Zealand Clinical Research
Auckland, New Zealand, 1010
Actively Recruiting
2
New Zealand Clinical Research
Christchurch, New Zealand, 8011
Actively Recruiting
Research Team
C
Chris Brett, MD
CONTACT
S
Sophie McKellar, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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