Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Belite Bio, Inc
Age
18–65
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
The subject is male or female (not of childbearing potential), 18 to 65 years of age, inclusive, at screening.
The subject voluntarily consents to participate in this study and
provides written informed consent before the start of any study-specific procedures.
The subject is willing and able to remain in the study unit for the entire duration of the confinement period and return for outpatient visits.
Female subjects must be of non-childbearing potential (defined as surgically sterile \[i.e., had a bilateral tubal ligation, hysterectomy, or
bilateral oophorectomy at least 6 months before the dose of study drug\] or postmenopausal for at least 1 year before study drug administration confirmed by FSH test at screening).
Male subjects must be surgically sterile (i.e., vasectomy) for at least 3 months before screening; or agree to use a condom with spermicide when sexually active with a female partner. Male subjects must also agree to refrain from sperm donation for 90 days after study drug administration.
The subject has a body mass index (BMI) of 18 to 30 kg/m2, inclusive, at screening and weighs 50 to 100 kg (110-220 pounds), inclusive, at screening and Check-in.
The subject is considered to be in stable health by the investigator
You may not be if
Any significant acute or chronic medical illness including history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease
Any recent viral or bacterial infection.
Participated in any clinical study in last 6 weeks.
History of significant drug allergy
History of significant vision, ocular or retinal disorder.
Recent surgery, blood transfusion, drug or alcohol abuse and use of tobacco or nicotine containing products in past month.
Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations
