A 3-Month Phase 2 Study to Evaluate the Safety and Efficacy of SPR001 in Subjects with Classic Congenital Adrenal Hyperplasia

Inclusion Criteria
Has a documented historical diagnosis of classic CAH due to 21-hydroxylase deficiency based on documented genetic mutation or elevated 17-OHP
Known or suspected differential diagnosis of any of the other known forms of CAH, including non-classic CAH
Is on a stable regimen of glucocorticoid replacement for greater than or equal to 30 days before baseline that is expected to remain stable throughout the study
Agrees to follow contraception guidelines. Male subjects must also agree
to refrain from donating sperm throughout the treatment period and for 90 days after
the last dose of study drug
Exclusion Criteria
Has had a clinically significant unstable medical condition, medically significant illness, or
chronic disease within 30 days of screening, including but not limited to:
A malignancy or 3 years of remission history from any malignancy, other than
uccessfully treated localized skin cancer
Presence of clinically significant renal disease
Current or chronic history of liver disease or known hepatic or biliary abnormalities
(with the exception of Gilbert?s syndrome or asymptomatic gallstones)
Confirmed positive test at screening for active hepatitis B, hepatitis C, or HIV
Has a history that includes bilateral adrenalectomy or hypopituitarism
Females who are pregnant or nursing
Use of any other investigational drug within 30 days or 5 half-lives (whichever is longer)
before screening
Use of prohibited concomitant medications, including rosiglitazone, testosterone, and strong inhibitors and/or inducers of CYP3A4 (with the exception of glucocorticoids and birth control) within 30 days or 5 half-lives (whichever is longer) of baseline
Donation of blood within 60 days before baseline or donation of platelets, white blood
cells, or plasma within 15 days before baseline