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First-In-Human Study to Evaluate Single and Multiple Ascending Doses of JUV-161 in Healthy Adult Volunteers 1상 40 최초 인체 적용
Data from this study will support conduct studies in patients with DM1 as w...
더 보기Enrollment in the SAD portion of the study will include up to 6 cohorts of 8 healthy adult volunteer subjects each of whom will receive a single dose of study drug (JUV-161, n=6; placebo, n=2). Enrollment in the MAD portion...
더 보기A Double-blind, Placebo-controlled, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single- and Multiple-ascending Doses of JUV-161 Administered Subcutaneously to Healthy Adult Volunteers.
- JUV-161-101
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
활성 대조군JUV-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 subjects SAD 6 JUV-161 10.0mg/kg 6 subjects
MAD 1 JUV-161 0.10 mg/kg 6 subjects X 3 doses MAD2 JUV-161 3.00 mg/kg 6 subjects X 3 doses MAD3 JUV-161 5.0 mg/kg 6 subjects x 3 dos...더 보기 | JUV-161, Placebo Single-Ascending, Placebo-Controlled |
위약 대조군Placebo-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 SAD 6 placebo 2 subjects X 1 dose
MAD 1 placebo 2 subjects x 3 doses MAD 2 placebo 2 subjects x 3 doses MAD 3 placebo 2 subjects x 3 doses | JUV-161, Placebo Single-Ascending, Placebo-Controlled |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Incidence of treatment-emergent adverse events | From enrollment through to safety follow-up Visit on Day 60 | |
Number of participants with treatment-emergent potentially clinically-significant safety abnormalities in safety laboratory parameters | From enrollment through to safety follow-up Visit on Day 60 | |
Number of participants who have changes from baseline in electrocardiogram values in QTcF intervals | From enrollment through the safety follow-up visit on Day 60 | |
Number of participants who have changes from baseline in heart rate ( beats per minute) | From enrollment through the safety follow-up visit on Day 60 | |
Number of participants who have a change from baseline in systolic and diastolic blood pressure (mmHg) | From enrollment through the safety follow-up visit on Day 60 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Maximum observed plasma concentration (Cmax) | 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 | |
Time to the maximum measured plasma concentration (Tmax): | Up to 60 days | |
Area under the concentration-time curve from time zero through to infinity (AUC0-∞) | Up to 60 days. | |
Terminal elimination half-life in plasma (t1/2) | Up to 60 days |
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.
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:
- 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
- Nonhormonal intrauterine device (IUD)
- Bilateral tubal occlusion
- 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.
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:
- Vasectomy with medical assessment of surgical success and consistent use of a condom OR
- 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.
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
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
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
Have any of the following:
- History of diabetes
- History of bleeding disorder or excessive bleeding
- Impaired renal function (estimated glomerular filtration rate \[eGFR\] <60ml/min/1.73m2, using the CKD-EPI (2021 equation) \[See Appendix 1.\]
- Platelet count < 125 X 109/L
- INR > ULN
- Electrocardiogram (ECG) showing QTcF > 470 msec female or > 450 msec male
Have received
- Treatment with any prescription medication within 14 days prior to screening (exception: contraceptives are permitted)
- 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)
- Any vaccination (therapeutic or prophylactic) within 30 days prior to screening and agree to not 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 7 days prior to screening.
Juvena TherapeuticsVictoria