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Study of SPR001 in Adults With Classic Congenital Adrenal Hyperplasia

NCT03257462 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-10-22

Study results available
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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).

Conditions

  • Congenital Adrenal Hyperplasia
  • CAH - Congenital Adrenal Hyperplasia

Interventions

DRUG

SPR001

SPR001 Capsules

Sponsors & Collaborators

  • Spruce Biosciences

    lead INDUSTRY

Principal Investigators

  • Spruce Chief Medical Officer, MD · Spruce Biosciences

  • Richard Auchus, MD, PhD · University of Michigan

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-12
Primary Completion
2019-03-02
Completion
2019-03-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03257462 on ClinicalTrials.gov