Healthy VolunteersPhase 1/2NCT07397468
To studyJUV-161 Administered to Healthy Volunteers Undergoing Unilateral Lower Limb Immobilization (ULLI)
A Phase 1/2 study testing JUV-161 in people with Healthy Volunteers, run by Juvena Therapeutics at 2 sites in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- JUV-161
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesNew Zealand
- Study dates
- 28 Feb 2026to 31 Aug 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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.)
Show all 31Show fewer
- 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)
- History of pulmonary emboli
- 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)
- History of connective tissue diseases (positive lupus anticoagulant), hyperhomocysteinemia, deficiencies of factor V Leiden, proteins S and C, and antithrombin III
- Impaired renal function (estimated glomerular filtration rate [eGFR] <60ml/min/1.73m2, using the CKD-EPI (2021) equation)
- Platelet count < 125 X 109/L
- Use of anticoagulants or INR > ULN
- Electrocardiogram (ECG) showing QTcF > 470 msec female or > 450 msec male
- 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.
- Any vaccination (therapeutic or prophylactic) within 30 days prior to screening and/or plans to receive any vaccination during the course of the study.
- Prior exposure to JUV-161 or have known allergies to any components of the JUV-161 formulation.
- History of immune reaction to any biologic therapy.
- Donation or loss of greater than 1 unit (450 mL) of blood or donation of plasma through plasmapheresis within 30 days prior to screening.
- 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.
- Use of hormone therapy e.g. estrogen within 60 days before Screening.
- Recent (within 3 months of screening) history of surgery or significant trauma.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
New Zealand2 sites, 2 recruiting
- Recruiting
New Zealand Clinical Research
Auckland, 1010
Sophie McKellar, MD, sophie.mckellar@nzcr.co.nz
- Recruiting
New Zealand Clinical Research
Christchurch, 8011
Chris Brett, MD, + 64 3 372 9477, christian.brett@nzcr.co.nz
Chris Brett, MD
About this study
Official title: Double-blind, Placebo-controlled, Randomized, Safety and Efficacy Study of JUV-161 Administered to Healthy Volunteers Undergoing Unilateral Lower Limb Immobilization (ULLI)
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.
Read the detailed description
JUV-161 is being developed for the treatment of muscle atrophy or sarcopenia and myotonic dystrophy. This study is investigating the safety and efficacy of JUV-161 administered in healthy participants who are undergoing unilateral lower limb immobilization (ULLI). Muscle atrophy is a general term to describe loss of muscle mass, whereas sarcopenia is a more specific term used to describe age-related loss of muscle. Muscle atrophy can be associated with a multitude of causes ranging from poor nutrition to neurological diseases, myopathies or disuse.
JUV-161 is an agonist designed to activate key signaling pathways in skeletal muscle, promoting muscle growth, maintenance, and strength, and may help prevent muscle atrophy during periods of immobilization. ULLI or unilateral lower limb suspension (ULLS) is often the consequence of common injuries such as falls, fractures or joint injuries. Because it isolates a specific group of muscles, it is also a frequently used model to study muscle disuse atrophy. In fact, ULLI/S using a brace or cast is the most frequent model used to study disuse atrophy.
This is a double-blind, placebo-controlled, randomized multicenter study of 96 days total duration. The purpose is to assess the effect of JUV-161 on muscle disuse atrophy. The study will include up to 40 healthy volunteers aged between 40 and 65 years of age (inclusive). Following the screening period, subjects will be randomized 1:1 to receive either weekly subcutaneous (SC) injections ofJUV-161 or a matching placebo for a period of approximately 6 weeks (total of 7 doses).
The study will be conducted in three phases:
- Immobilization to induce disuse muscle atrophy. Subjects will have one leg immobilized using a brace and boot to prevent weight bearing. (Crutches will be provided). The leg will be immobilized for 14 days, then the brace/boot will be removed.
- Recovery (mobilization) After the brace/boot is removed, subjects will undergo a 4-week period of mobilization to help restore muscle mass and strength lost in the immobilized leg
- Resistance exercise training (RET) After 4 weeks of mobilization, subjects will undergo a further 3 weeks of personalized (RET) to fully restore muscle mass and strength in the immobilized leg. Participants and researchers will be blinded to the study allocation. Every person in the study will have their dominant leg fitted with a brace, which they will wear for 15 days. They will then receive 5mg/kg of the JUV-161 (or matching placebo) once a week for 6 weeks (7 doses total). This will be given as a subcutaneous (SC) injection in the abdomen or thigh. The study design includes an option for a single escalation of the JUV-161 dose based on SRC review of blinded aggregate safety data after 18 participants in the initial dose group have completed the first 14 days of treatment with study drug.
If dose escalation is supported, no further participants will be enrolled in the initial dosing group, and 18 subjects will be enrolled in the higher dose group. If dose escalation is not supported by safety data, enrollment of further participants will continue in the initial dosing group until a total of 36 subjects have been enrolled.
- Conditions
- Healthy Volunteers
- Being tested
- JUV-161, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JUV-161Drug
JUV-161 administered subcutaneously at protocol-specified dose levels.
PlaceboDrug
Also called Matched Placebo
Matched placebo administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
Measured: 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.
Measured: 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,
Measured: 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 in serum concentrations of myostatin and follistatin, measured using validated immunoassays.
Measured: 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 in serum concentrations of insulin-like growth factor-1 (IGF-1) and human growth hormone, measured using validated immunoassays.
Measured: 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 in serum concentrations of interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-α), measured using validated immunoassays.
Measured: Change from baseline (pre-treatment) to Day 15 (post-immobilization) and Day 45 (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start28 Feb 2026
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind, placebo controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juvena Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris Brett, MD, Principal investigator, NZCR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397468
- Sponsor's protocol ID
- JUV161-201
- Status last verified
- Apr 2026
- First submitted
- 27 Jan 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-controlled, Randomized, Safety and Efficacy Study of JUV-161 Administered to Healthy Volunteers Undergoing Unilateral Lower Limb Immobilization (ULLI)
- ClinicalTrials.gov ID
- NCT07397468
- Acronym / sponsor ID
- JUV161-201
- Conditions
- Healthy Volunteers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Juvena TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
JUV-161 is being developed for the treatment of muscle atrophy or sarcopenia and myotonic dystrophy. This study is investigating the safety and efficacy of JUV-161 administered in healthy participants who are undergoing unilateral lower limb immobilization (ULLI). Muscle atrophy is a general term to describe loss of muscle mass, whereas sarcopenia is a more specific term used to describe age-related loss of muscle. Muscle atrophy can be associated with a multitude of causes ranging from poor nutrition to neurological diseases, myopathies or disuse.
JUV-161 is an agonist designed to activate key signaling pathways in skeletal muscle, promoting muscle growth, maintenance, and strength, and may help prevent muscle atrophy during periods of immobilization. ULLI or unilateral lower limb suspension (ULLS) is often the consequence of common injuries such as falls, fractures or joint injuries. Because it isolates a specific group of muscles, it is also a frequently used model to study muscle disuse atrophy. In fact, ULLI/S using a brace or cast is the most frequent model used to study disuse atrophy.
This is a double-blind, placebo-controlled, randomized multicenter study of 96 days total duration. The purpose is to assess the effect of JUV-161 on muscle disuse atrophy. The study will include up to 40 healthy volunteers aged between 40 and 65 years of age (inclusive). Following the screening period, subjects will be randomized 1:1 to receive either weekly subcutaneous (SC) injections ofJUV-161 or a matching placebo for a period of approximately 6 weeks (total of 7 doses).
The study will be conducted in three phases:
- Immobilization to induce disuse muscle atrophy. Subjects will have one leg immobilized using a brace and boot to prevent weight bearing. (Crutches will be provided). The leg will be immobilized for 14 days, then the brace/boot will be removed.
- Recovery (mobilization) After the brace/boot is removed, subjects will undergo a 4-week period of mobilization to help restore muscle mass and strength lost in the immobilized leg
- Resistance exercise training (RET) After 4 weeks of mobilization, subjects will undergo a further 3 weeks of personalized (RET) to fully restore muscle mass and strength in the immobilized leg. Participants and researchers will be blinded to the study allocation. Every person in the study will have their dominant leg fitted with a brace, which they will wear for 15 days. They will then receive 5mg/kg of the JUV-161 (or matching placebo) once a week for 6 weeks (7 doses total). This will be given as a subcutaneous (SC) injection in the abdomen or thigh. The study design includes an option for a single escalation of the JUV-161 dose based on SRC review of blinded aggregate safety data after 18 participants in the initial dose group have completed the first 14 days of treatment with study drug.
If dose escalation is supported, no further participants will be enrolled in the initial dosing group, and 18 subjects will be enrolled in the higher dose group. If dose escalation is not supported by safety data, enrollment of further participants will continue in the initial dosing group until a total of 36 subjects have been enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- double-blind, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| JUV-161 5mg/kg | Experimental | Drug: JUV-161Participants will receive JUV-161 5 mg/kg administered subcutaneously Each subject will receive 7 doses in total over 6 weeks. |
| JUV-161 10 mg/kg | Experimental | Drug: JUV-161Participants 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. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matched placebo administered subcutaneously. Each participant will receive a total of 7 doses over a 6-week dosing period. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.)
Key exclusion criteria (31 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JUV-161JUV-161 administered subcutaneously at protocol-specified dose levels. | Drug | JUV-161 10 mg/kg, JUV-161 5mg/kg |
| PlaceboAlso: Matched PlaceboMatched placebo administered subcutaneously | Drug | Placebo |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline (pre-treatment) to Day 15 (post-immobilization) and Day 45 (post-treatment)
includes individual muscle volume, intramuscular fat fraction, spatial distribution of fat fraction, and quantification of short tau inversion recovery (STIR) hyperintensity,
3 secondary outcomes
Change from baseline in pharmacodynamic biomarkers of target engagement (myostatin and follistatin)
Time frame: 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)
Time frame: 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)
Time frame: Change from baseline (pre-treatment) to Day 15 (post-immobilization) and Day 45 (post-treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chris Brett, MD principal investigator
NZCR
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JUV-161 in people with Healthy Volunteers, run by Juvena Therapeutics at 2 sites in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chris Brett, MD (+ 64 3 372 9477, christian.brett@nzcr.co.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (time frame: from enrollment through to Day 96). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.