First-In-Human Study to Evaluate Single and Multiple Ascending Doses of JUV-161 in Healthy Adult Volunteers

Inclusion Criteria:

1. Are males or nonpregnant females, ages 18 to 60 (inclusive) at time of signingInformed 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 andrequirements

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, vitalsigns 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 priorto dosing through Post-dosing visit on Study Day 6.

9. Females must be either:

• of non-childbearing potential (defined as having undergone surgicalsterilization (hysterectomy, bilateral salpingectomy, bilateral oophorectomy orbeing postmenopausal (i.e., greater than 45 years old with amenorrhea for ≥ 12months).) [Women under the age of 55 years must have a follicle stimulatinghormone (FSH) level > 40mIU/mL to confirm menopause] OR

• of child-bearing potential and using at least one of the following acceptablemethods of contraception from at least 30 days prior to the time of informedconsent through the time of study drug administration and for 8 weeks afterlast administration of study drug:

1. Hormonal methods of contraception, including oral contraceptivescontaining combined estrogen and progesterone, a vaginal ring, injectableand implantable hormonal contraceptives, intrauterine hormone-releasingsystem (e.g., Mirena) and progestogen-only hormonal contraceptionassociated with inhibition of ovulation

2. Nonhormonal intrauterine device (IUD)

3. Bilateral tubal occlusion

4. Vasectomized subject/partner with documented azoospermia 90 days afterprocedure, if that partner is the sole sexual partner NOTE: WOCBP who arenot exclusively in same-sex relationships must agree to use adequatecontraception. WOCBP who are continuously not heterosexually active areexempt from contraceptive requirements. However, WOCBP must still undergopregnancy testing as per protocol. NOTE: Complete abstinence, defined as the complete avoidance of heterosexualintercourse - is an acceptable form of contraception if used consistently throughoutthe duration of study and for the durations after dosing specified for males andfemales above. It is not necessary to use any other method of contraception whencomplete abstinence is elected. WOCBP who choose complete abstinence must continueto have pregnancy tests as per protocol. The reliability of sexual abstinence needsto be evaluated by the Investigator in relation to the duration of the clinicaltrial and the preferred and usual lifestyle of the subject. NOTE: Female subjects must avoid egg donation from Screening through at least 2months after administration of the last dose of study drug.

5. Men who are sexually active and males with partners of child-bearing potential mustuse the following forms of medically acceptable birth control during the study drugtreatment period and for 16 weeks after the last administration of study drug:

6. Vasectomy with medical assessment of surgical success and consistent use of acondom OR

7. Consistent use of a condom with partner also using either stable hormonalcontraceptive or IUD. NOTE: Males who are continuously not heterosexually active are exempt fromcontraceptive requirements. NOTE: Sperm donation is prohibited during the study and for up to 120 days4 monthsafter the last administration of study drug.

8. 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

Exclusion Criteria:

1. Are unwilling or unable to comply with study procedures, including follow-up, asspecified 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 priorto Screening. (Subjects with prior basal or squamous cell carcinoma of the skin orcarcinoma in situ of the cervix that were successfully treated may be enrolled.)

4. Have any of the following known active infections:

5. Infection requiring systemic antiviral or antimicrobial therapy that would nothave been completed within 30 days prior to screening

6. Known history or positive test result for HIV, HBV or HCV

7. Have any clinical history or other active medical condition, psychiatric disorder orclinically significant laboratory abnormality, vital sign, ECG abnormality or otherfinding that, in the investigator's opinion, is likely to increase the risk of studyparticipation, confound study results, or interfere with study conduct or adherence

8. Have any of the following:

9. History of diabetes

10. History of bleeding disorder or excessive bleeding

11. Impaired renal function (estimated glomerular filtration rate [eGFR] <60ml/min/1.73m2, using the CKD-EPI (2021 equation) [See Appendix 1.]

12. Platelet count < 125 X 109/L

13. INR > ULN

14. Electrocardiogram (ECG) showing QTcF > 470 msec female or > 450 msec male

15. Have received

16. Treatment with any prescription medication within 14 days prior to screening (exception: contraceptives are permitted)

17. 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 perday prior to dosing is permitted)

18. Any vaccination (therapeutic or prophylactic) within 30 days prior to screeningand agree to not receive any vaccination during the course of the study

19. Prior exposure to JUV-161 or have known allergies to any components of the JUV-161formulation

20. History of immune reaction to any biologic therapy

21. Donation or loss of greater than 1 unit (450 mL) of blood or donation of plasmathrough plasmapheresis within 7 days prior to screening.