The main objective of this study is to evaluate the efficacy of different dose levels of NBIP-01435 on reducing elevated androstenedione (A4) levels in adults with classic CAH.
Medically confirmed diagnosis of classic 21-hydroxylase deficiency (21-OHD) CAH, based on standard, medically accepted criteria.
Stable glucocorticoid (GC) dose regimen for classic CAH for a minimum of 30 days before screening.
If treated with fludrocortisone, the dose should be stable for at least 30 days before screening with an upright plasma renin activity (PRA) <upper limit of normal (ULN) on participant's usual sodium intake.
Have elevated A4, based on a blood sample collected at screening.
Pregnant (that is, positive pregnancy test), or lactating, or plan to become pregnant during the study.
Had a clinically significant illness within 30 days of screening.
Have a known or suspected diagnosis of any of the other known forms of classic CAH.
Parallel
NBIP-01435
DrugNBIP-01435 will be administered per schedule specified in the arm description.
Change From Baseline in A4 Level at Week 8
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