First-In-Human Study to Evaluate Single and Multiple Ascending Doses of JUV-161 in Healthy Adult … (NCT06918925) | Clinical Trial Compass
Active — Not RecruitingPhase 1
First-In-Human Study to Evaluate Single and Multiple Ascending Doses of JUV-161 in Healthy Adult Volunteers
Australia72 participantsStarted 2025-04-14
Plain-language summary
The present First-In-Human (FIH) study (JUV-161-101) aims to assess the safety, tolerability, and pharmacokinetics (PK) of single and multiple subcutaneous (SC) doses of JUV-161 in healthy volunteers. The study design is well-established for FIH studies and appropriate to assess the preliminary safety and tolerability of new drug candidates.
Data from this study will support conduct studies in patients with DM1 as well as supporting studies in other degenerative myopathies and other disorders for which preclinical efficacy data have been obtained.JUV-161 has not been previously been administered to human subjects.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Are males or nonpregnant females, ages 18 to 60 (inclusive) at time of signing Informed Consent with body mass index (BMI) 18 to 35 kg/m2
✓. Are willing and able to give informed consent and follow all study procedures and requirements
✓. Are able to understand the requirements of the study protocol
✓. Agree to complete all required study visits
✓. Are healthy, based on physical examination, medical history laboratory tests, vital signs and resting electrocardiograms
✓. Are willing to abstain from caffeine and nicotine while in the Study Unit
✓. Have negative screens for alcohol and drugs of abuse at screening and admission
✓. Are willing to abstain from all alcoholic beverages and cannabinoids for 48 h prior to dosing through Post-dosing visit on Study Day 6.
Exclusion criteria
✕. Are unwilling or unable to comply with study procedures, including follow-up, as specified by the protocol, or unwilling to cooperate fully with the Investigator
What they're measuring
1
Incidence of treatment-emergent adverse events
Timeframe: From enrollment through to safety follow-up Visit on Day 60
2
Number of participants with treatment-emergent potentially clinically-significant safety abnormalities in safety laboratory parameters
Timeframe: From enrollment through to safety follow-up Visit on Day 60
3
Number of participants who have changes from baseline in electrocardiogram values in QTcF intervals
Timeframe: From enrollment through the safety follow-up visit on Day 60
4
Number of participants who have changes from baseline in heart rate ( beats per minute)
Timeframe: From enrollment through the safety follow-up visit on Day 60
5
Number of participants who have a change from baseline in systolic and diastolic blood pressure (mmHg)
Timeframe: From enrollment through the safety follow-up visit on Day 60
✕. Have a history of drug or alcohol abuse within 3 months of Screening
✕. Have an active malignancy or have a history of malignancy within the 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 enrolled.)
✕. Have any of the following known active infections:
✕. Infection requiring systemic antiviral or antimicrobial therapy that would not have been completed within 30 days prior to screening
✕. Known history or positive test result for HIV, HBV or 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, or interfere with study conduct or adherence