CTIS2023-503488-40-00进行中（未招募）1 期
A 12-Week, Phase 2 Open-Label, Sequential Dose Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of CRN04894 Treatment in Participants with Congenital Adrenal Hyperplasia - CRN04894-03
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Male or female participants =18 to 75 years of age at the time of signing the Informed Consent Form (ICF). Participants =16 years of age may be included in sites located in the United States (US), Classic 21-hydroxylase deficiency confirmed by the Investigator and approved by the Medical Monitor., On a stable (defined as no dose change of >5 mg/day hydrocortisone equivalent (see Section 12.5) within 6 months prior to Screening) regimen of glucocorticoid replacement (eg, hydrocortisone, prednisolone, prednisone, methylprednisolone)., Compliance, as judged per investigator discretion, with glucocorticoid replacement and mineralocorticoid replacement (if applicable) regimen documented during the Screening Period, Minimum total daily dose of =15 mg hydrocortisone (or equivalent), If on estrogen therapy (any route), dose must be stable for at least 3 months prior to Screening.
排除标准
- •Diagnosis of any other form of CAH other than classic 21-hydroxylase deficiency, History of unstable angina or acute myocardial infarction within 12 weeks prior to Screening or other clinically significant cardiac disease at the time of Screening as judged by the Investigator, Concomitant mental condition rendering him/her unable to understand the nature, scope, and possible consequences of the study, and/or evidence of poor compliance with medical instructions, History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ, Women who are pregnant or lactating or, if of childbearing potential, who are unwilling to use highly effective contraception as described in this study. Male participants who are unwilling to use highly effective contraception as described in this study., Known history of illicit drug or alcohol abuse within the last year, Use of antiandrogen therapy in the past 3 months (eg, spironolactone, finasteride, cyproterone acetate, flutamide), Use of testosterone, androgen-containing supplements, aromatase inhibitors, or growth hormone, Dexamethasone or oral betamethasone use within 30 days of Screening, History of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy, Night shift workers or any other reason for abnormal sleep/wake cycles, Clinically significant medical condition or abnormal laboratory tests, as judged by the Investigator, other than CAH, History of major surgery/surgical therapy for any cause within 4 weeks prior to Screening, Diabetes mellitus treated with insulin for less than 6 weeks prior to Screening, or with change in total daily insulin dose by >15% within 6 weeks prior to Screening, Poorly controlled diabetes mellitus defined as having a hemoglobin A1c (HbA1c) =8.5%(=69 mmol/mL), or estimated HbA1c based on fructosamine if HbA1c is not evaluable (eg, due to hemoglobinopathies), Participants with hypothyroidism who are not receiving adequate hormone replacement therapy based on thyroid hormone levels measured at the time of Screening, as determined by the Investigator
研究者
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