A Phase I, Randomized, Double-blinded, Placebo-Controlled First-in-human Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of J4 Dry Powder Capsule After Oral Administration of Single and Multiple Ascending Doses to Healthy Adults
A Phase I, Randomized, Double-blinded, Placebo-Controlled First-in-human Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of J4 Dry Powder Capsule after Oral Administration of Single and Multiple Ascending Doses to Healthy Adults
• Healthy male and female subjects between 18 and 64 (inclusive) years of age at the time of consent
• Body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive); male subjects must weigh a minimum of 50 kg while female subjects must weigh a minimum of 45 kg.
• Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, vital sign measurement, ECG, and clinical laboratory test results.
• Male subjects with a female partner of childbearing potential are eligible to participate if they meet either of the following conditions:
‣ They are surgically or biologically sterile (surgically sterile is defined as vasectomy with documented negative semen analysis/azoospermia).
⁃ They commit to the use of highly effective methods of contraception (defined as those that, alone or in combination, result in a failure rate less than 1 percent per year) from study Day -1 until 90 days after the last dose of the study drug. Male subject must use a condom, and the subject's female partner must use either an occlusive cap (cervical cap or diaphragm) with spermicide or an intrauterine device.
⁃ They are abstinent from intercourse from study Day -1 until 90 days after the last dose of the study drug.
• Male subjects must agree to refrain from sperm donation and females refrain from ova donation from Study Day -1 until 90 days after the last dose of the study drug.
• Female subjects of childbearing potential (which is defined as any woman or adolescent who has begun menstruation) are eligible to participate if they meet either of the following conditions:
‣ They are surgically of biologically sterile (surgically sterile is defined as the subject has one of the following: documented hysterectomy, documented bilateral salpingectomy, documented bilateral oophorectomy). If they have undergone tubal ligation, the procedure must have occurred at least 6 weeks prior to the 1st study drug administration.
⁃ They commit to use of highly effective methods of contraception, starting from at least 30 days prior to 1st study drug administration and continuing for at least 90 days after the last dose of the study drug. The highly effective methods include the use of condom by the male partner, in combination with one of the following by the female participant:
• Occlusive cap (cervical cap or diaphragm) with spermicide
∙ Intrauterine device
⁃ The subject has a vasectomized male partner with documented negative semen analysis/azoospermia, provided that the partner is the sole sexual partner of the female subject.
⁃ They perform sexual abstinence from at least 30 days prior to the 1st study drug administration and until at least 90 days after the last dose of the study drug.
• Female subjects of postmenopausal state must be amenorrhea for at least 2 years or have no menses for 12 month and a high FSH level in postmenopausal range.
• Provide signed informed consent prior to any study procedures commencing, understand and comply with the requirements of the study, and be able to communicate with the investigator.