Single-dose Escalation Study of SQ-001 Infusion to Characterize the PK Profiles of Major Sentinel Compounds in Healthy Adult Volunteers in US

Inclusion Criteria

• •1. Subjects must be medically documented as healthy at the time of screening as determined by their medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests, unless the Investigator considers an abnormality to be clinically irrelevant.
• •2. Subjects must be within 18 to 65 years old and not currently using tobacco products.
• •3. Subjects must have a BMI within 18 to 32 kg/m2.
• •4. Females
• •1. Surgically sterilized (e.g., hysterectomy or bilateral oophorectomy) for at least 6 months prior to screening or postmenopausal (postmenopausal women must have no menstrual bleeding for at least 1 year prior to screening and menopause will be confirmed by a plasma FSH level of \>30 IU/L) or
• •2. Women of child-bearing potential must be non-lactating and agree to use a highly effective acceptable form of birth control such as surgical sterilization (e.g., tubal ligation), or total abstinence from sexual intercourse with the opposite sex, or established hormonal birth control (e.g. oral, implant or injection) plus a barrier method, or a double barrier method (e.g. intrauterine device plus condom or spermicidal gel plus condom or diaphragm plus condom) from 14 days prior to dosing until 30 days after dosing.
• •3. Women with a negative serum pregnancy test (βhCG assay) at screening and at Day -1 (urine)
• •4. For non-sexually active females, abstinence may be regarded as an adequate method of birth control, but if the subject becomes sexually active during the study, she must use adequate birth control as defined above for the remainder of the study.
• •5. Males Must be willing to use highly effective forms of acceptable birth control (e.g., vasectomy, total abstinence from sexual intercourse with the opposite sex, sexual intercourse with a woman who is not of childbearing potential) from Day 1 dosing to Day 90 after dose.
• •6. Subjects must be able to comply with the study and follow-up procedures.
• •7. Subjects must provide a signed informed consent to participate in the study.
• •8. Subjects must not have participated in any clinical trial within 30 days.