Study of SPR001 in Adults With Classic Congenital Adrenal Hyperplasia

• Status: Completed
• Trial end date: 2019-05-28
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter Phase 2, multiple dose, dose escalation study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SPR001 in adult patients with classic congenital adrenal hyperplasia (CAH).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spruce Biosciences

Criteria

Inclusion Criteria:

• Male and female patients age 18 or older.

• Documented diagnosis of classic CAH due to 21-hydroxylase deficiency

• Elevated 17-OHP at screening

• On a stable glucocorticoid replacement regimen for a minimum of 30 days

Exclusion Criteria:

• Clinically significant unstable medical condition, illness, or chronic disease

• Clinically significant psychiatric disorder.

• Clinically significant abnormal laboratory finding or assessment

• History of bilateral adrenalectomy or hypopituitarism

• Pregnant or nursing females

• Use of any other investigational drug within 30 days

• Unable to understand and comply with the study procedures, understand the risks, and/or unwilling to provide written informed consent.