Status:
COMPLETED
Study of SPR001 in Adults With Classic Congenital Adrenal Hyperplasia
Lead Sponsor:
Spruce Biosciences
Conditions:
Congenital Adrenal Hyperplasia
CAH - Congenital Adrenal Hyperplasia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 congenit...
Detailed Description
This is a 6-week, multiple-dose, dose escalation study of SPR001 for the treatment of adults with classic CAH. After screening, eligible patients will be enrolled into a 6-week treatment period follow...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03257462
Start Date
July 12 2017
End Date
March 29 2019
Last Update
October 22 2025
Active Locations (9)
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1
Spruce Biosciences Clinical Site
Orange, California, United States, 92123
2
Spruce Biosciences Clinical Site
San Diego, California, United States, 92123
3
Spruce Biosciences Clinical Site
Melbourne, Florida, United States, 32935
4
Spruce Biosciences Clinical Site
Atlanta, Georgia, United States, 30046