A Phase 1 Study of CG001419 Administered Orally in Healthy Subjects

Inclusion criteria

• ✓. Refrain from donating sperm
• ✓. Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR
• ✓. Agree to use a male condom (contraception/barrier) and should also be advised of the benefit for a female partner to use an acceptable, highly effective method of contraception (of low user dependency or is user dependent), as a condom may break or leak when having sexual intercourse 5. Female subjects are eligible to participate if they are not pregnant or breastfeeding and fall under 1 of the following criteria:
• ✓. Women of childbearing potential (WOCBP), defined as women physiologically capable of becoming pregnant, must have a negative serum pregnancy test at the Screening visit and a negative urine pregnancy test on Day -1; WOCBP must agree to be abstinent from heterosexual intercourse or use an acceptable, highly effective contraceptive method (of low user dependency or is user dependent) from Screening and not donate eggs until 30 days after the last dose of the study drug.
• ✓. Menopausal women must have an elevated serum follicle-stimulating hormone level (FSH \>40 IU/mL) level at Screening; if the FSH is not elevated, they are considered to be of childbearing potential (unless permanently sterile).