To studyJUV-161 Administered to Healthy Volunteers Undergoing Unilateral Lower Limb Immobilization (ULLI)

NCT07397468 | Recruiting Phase 1 DMC

• 1 other identifier: JUV161-201
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

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

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Incidence of treatment-emergent adverse events

  from enrollment through to Day 96

• Number of Participants who have Change in Quadriceps Muscle Mass and Volume as assessed by magnetic resonance imaging MRI.

  Change from baseline (pre-treatment) to Day 15 (post-immobilization) and Day 45 (post-treatment)

• Number of participants who have Change in lower limb muscle architecture as assessed by MRI.

  includes individual muscle volume, intramuscular fat fraction, spatial distribution of fat fraction, and quantification of short tau inversion recovery (STIR) hyperintensity,

  Change from baseline (pre-treatment) to Day 15 (post-immobilization) and Day 45 (post-treatment)

Secondary Outcomes (3)

• Change from baseline in pharmacodynamic biomarkers of target engagement (myostatin and follistatin)

  Change from baseline (pre-treatment) to Day 15 (post-immobilization) and Day 45 (post-treatment)

• Change from baseline in myogenesis-related biomarkers (IGF-1 and human growth hormone)

  Change from baseline (pre-treatment) to Day 15 (post-immobilization) and Day 45 (post-treatment)

• Change from baseline in metabolic and inflammatory biomarkers (IL-6, TNF-α)

  Change from baseline (pre-treatment) to Day 15 (post-immobilization) and Day 45 (post-treatment)

Other Outcomes (11)

• Number of participants who have Change in Lower Limb Muscle Strength as assessed by isokinetic dynamometry (force output).

  Change from baseline (pre-treatment) to Day 15 (post-immobilization) and Day 45 (post-treatment)

• Number of Participants who have Change in Lower Limb Force Production as assessed by single-leg vertical jump height.

  Change from baseline (pre-treatment) to Day 15 (post-immobilization) and Day 45 (post-treatment)

• Number of participants who have Change in Lower Limb Muscle Fatigue as assessed by single-leg vertical jump height

  hange from baseline (pre-treatment) to Day 15 (post-immobilization) and Day 45 (post-treatment)

Study Arms (3)

JUV-161 5mg/kg

EXPERIMENTAL

Participants will receive JUV-161 5 mg/kg administered subcutaneously Each subject will receive 7 doses in total over 6 weeks.

Drug: JUV-161

JUV-161 10 mg/kg

EXPERIMENTAL

Participants will receive JUV-161 at a dose of 10 mg/kg administered subcutaneously, contingent upon Safety Committee approval for dose escalation. Each participant will receive a total of 7 doses over a 6-week dosing period.

Drug: JUV-161

Placebo

PLACEBO COMPARATOR

Participants will receive matched placebo administered subcutaneously. Each participant will receive a total of 7 doses over a 6-week dosing period.

Drug: Placebo

Interventions

JUV-161 DRUG

JUV-161 administered subcutaneously at protocol-specified dose levels.

JUV-161 10 mg/kg; JUV-161 5mg/kg

Placebo DRUG

Matched placebo administered subcutaneously

Also known as: Matched Placebo

Placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Willing and able to give informed consent and comply with the requirements of the protocol, including muscle biopsy.
• Are healthy in the opinion of the Investigator, based on physical examination, medical history, clinical laboratory tests, vital signs, and resting electrocardiogram.
• BMI ≤ 30 kg/m2
• 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.)

You may not qualify if:

• Any anabolic steroid use or any condition that might affect muscle mass or strength
• Participation in resistance or strength training at a frequency \>1 time/week within 30-days prior to screening
• 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.
• 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.
• 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).
• 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.)
• Have any of the following known active infections:
• Infection requiring systemic antiviral or antimicrobial therapy that will not be completed within 30 days prior to screening
• 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).
• 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.
• Implanted electronic device e.g. pace-maker, ICD, nerve stimulator, infusion pump.
• Have any of the following:
• 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)
• History of bleeding disorder or excessive bleeding
• At risk for, or previous history of deep vein thrombosis (DVT) (including family history)

Sponsors & Collaborators

• Juvena Therapeutics: lead

Study Sites (2)

New Zealand Clinical Research

Auckland, 1010, New Zealand

RECRUITING

New Zealand Clinical Research

Christchurch, 8011, New Zealand

RECRUITING

Study Officials

• Chris Brett, MD

  NZCR

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris Brett, MD

CONTACT

+ 64 3 372 9477; christian.brett@nzcr.co.nz

Sophie McKellar, MD

CONTACT

+ 64 9 373 3474; Sophie.McKellar@nzcr.co.nz

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: quadruple
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: double-blind, placebo controlled

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 9, 2026
• Study Start: February 28, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2)