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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06918925




Registration number
NCT06918925
Ethics application status
Date submitted
24/03/2025
Date registered
9/04/2025
Date last updated
17/04/2025

Titles & IDs
Public title
First-In-Human Study to Evaluate Single Ascending Doses of JUV-161 in Healthy Adult Volunteers
Scientific title
A Double-Blind, Placebo-Controlled, First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of JUV-161 Administered Subcutaneously to Healthy Adult Volunteers
Secondary ID [1] 0 0
JUV-161-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - JUV-161, Placebo

Active comparator: JUV-161 - Single-ascending dose administration of JUV-161/ 5 cohorts of 6 subjects SAD 1 JUV-161 0.10 mg/kg 6 subjects SAD 2 JUV-161 0.30 mg/kg 6 subjects SAD 3 JUV-161 1.00 mg/kg 6 subjects SAD 4 JUV-161 3.00 mg/kg 6 subjects SAD 5 JUV-161 5.0 mg/kg 6

Placebo comparator: Placebo-Controlled - SAD1 placebo 2 subjects X 1 dose SAD 2 placebo 2 subjects X 1 dose SAD 3 placebo 2 subjects X 1 dose SAD 4 placebo 2 subjects X 1 dose SAD 5 placebo 2 subjects X 1 dose


Treatment: Drugs: JUV-161, Placebo
Single-Ascending, Placebo-Controlled
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment-emergent adverse events
Timepoint [1] 0 0
From enrollment through to safety follow-up Visit on Day 60
Primary outcome [2] 0 0
Number of participants with treatment-emergent potentially clinically-significant safety abnormalities in safety laboratory parameters
Timepoint [2] 0 0
From enrollment through to safety follow-up Visit on Day 60
Primary outcome [3] 0 0
Number of participants who have changes from baseline in electrocardiogram values in QTcF intervals
Timepoint [3] 0 0
From enrollment through the safety follow-up visit on Day 60
Primary outcome [4] 0 0
Number of participants who have changes from baseline in heart rate ( beats per minute)
Timepoint [4] 0 0
From enrollment through the safety follow-up visit on Day 60
Primary outcome [5] 0 0
Number of participants who have a change from baseline in systolic and diastolic blood pressure (mmHg)
Timepoint [5] 0 0
From enrollment through the safety follow-up visit on Day 60
Secondary outcome [1] 0 0
Maximum observed plasma concentration (Cmax)
Timepoint [1] 0 0
Day 1 pre-dose and at 1, 2, 6, 12, 24, 36, 48, 60 and 72 hours Day 6,8,11,15,18,21 and 60
Secondary outcome [2] 0 0
Time to the maximum measured plasma concentration (Tmax):
Timepoint [2] 0 0
Up to 60 days
Secondary outcome [3] 0 0
Area under the concentration-time curve from time zero through to infinity (AUC0-8)
Timepoint [3] 0 0
Up to 60 days.
Secondary outcome [4] 0 0
Terminal elimination half-life in plasma (t1/2)
Timepoint [4] 0 0
Up to 60 days

Eligibility
Key inclusion criteria
1. 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
2. Are willing and able to give informed consent and follow all study procedures and requirements
3. Are able to understand the requirements of the study protocol
4. Agree to complete all required study visits
5. Are healthy, based on physical examination, medical history laboratory tests, vital signs and resting electrocardiograms
6. Are willing to abstain from caffeine and nicotine while in the Study Unit
7. Have negative screens for alcohol and drugs of abuse at screening and admission
8. Are willing to abstain from all alcoholic beverages and cannabinoids for 48 h prior to dosing through Post-dosing visit on Study Day 6.
9. Females must be either:

* of non-childbearing potential (defined as having undergone surgical sterilization (hysterectomy, bilateral salpingectomy, bilateral oophorectomy or being postmenopausal (i.e., greater than 45 years old with amenorrhea for = 12 months).) [Women under the age of 55 years must have a follicle stimulating hormone (FSH) level > 40mIU/mL to confirm menopause] OR
* of child-bearing potential and using at least one of the following acceptable methods of contraception from at least 30 days prior to the time of informed consent through the time of study drug administration and for 8 weeks after last administration of study drug:

1. Hormonal methods of contraception, including oral contraceptives containing combined estrogen and progesterone, a vaginal ring, injectable and implantable hormonal contraceptives, intrauterine hormone-releasing system (e.g., Mirena) and progestogen-only hormonal contraception associated with inhibition of ovulation
2. Nonhormonal intrauterine device (IUD)
3. Bilateral tubal occlusion
4. Vasectomized subject/partner with documented azoospermia 90 days after procedure, if that partner is the sole sexual partner NOTE: WOCBP who are not exclusively in same-sex relationships must agree to use adequate contraception. WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, WOCBP must still undergo pregnancy testing as per protocol.

NOTE: Complete abstinence, defined as the complete avoidance of heterosexual intercourse - is an acceptable form of contraception if used consistently throughout the duration of study and for the durations after dosing specified for males and females above. It is not necessary to use any other method of contraception when complete abstinence is elected. WOCBP who choose complete abstinence must continue to have pregnancy tests as per protocol. The reliability of sexual abstinence needs to be evaluated by the Investigator in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.

NOTE: Female subjects must avoid egg donation from Screening through at least 2 months after administration of the last dose of study drug.
10. Men who are sexually active and males with partners of child-bearing potential must use the following forms of medically acceptable birth control during the study drug treatment period and for 16 weeks after the last administration of study drug:

1. Vasectomy with medical assessment of surgical success and consistent use of a condom OR
2. Consistent use of a condom with partner also using either stable hormonal contraceptive or IUD.

NOTE: Males who are continuously not heterosexually active are exempt from contraceptive requirements.

NOTE: Sperm donation is prohibited during the study and for up to 120 days4 months after the last administration of study drug.
11. Have NOT participated in a clinical study utilizing an investigational agent within 28 days or within 5 half-lives of the investigational drug (whichever is longer) prior to Screening
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. 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
2. Have a history of drug or alcohol abuse within 3 months of Screening
3. 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.)
4. Have any of the following known active infections:

1. Infection requiring systemic antiviral or antimicrobial therapy that would not have been completed within 30 days prior to screening
2. Known history or positive test result for HIV, HBV or HCV
5. 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
6. Have any of the following:

1. History of diabetes
2. History of bleeding disorder or excessive bleeding
3. Impaired renal function (estimated glomerular filtration rate [eGFR] <60ml/min/1.73m2, using the CKD-EPI (2021 equation) [See Appendix 1.]
4. Platelet count < 125 X 109/L
5. INR > ULN
6. Electrocardiogram (ECG) showing QTcF > 470 msec female or > 450 msec male
7. Have received

1. Treatment with any prescription medication within 14 days prior to screening (exception: contraceptives are permitted)
2. Treatment with any non-prescription medication within 7 days or 5 half-lives (whichever is longer) prior to dosing (exception: acetaminophen up to 2 g per day prior to dosing is permitted)
3. Any vaccination (therapeutic or prophylactic) within 30 days prior to screening and agree to not receive any vaccination during the course of the study
8. Prior exposure to JUV-161 or have known allergies to any components of the JUV-161 formulation
9. History of immune reaction to any biologic therapy
10. Donation or loss of greater than 1 unit (450 mL) of blood or donation of plasma through plasmapheresis within 7 days prior to screening.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/04/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Juvena Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Philip Ryan, MD
Address 0 0
Nucleus Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Shari Burgess
Address 0 0
Country 0 0
Phone 0 0
6476687627
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06918925