NCT05745883已完成1 期
A Phase 1b Multicenter, Randomized, Double-Blind, Placebo-Controlled Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DISC-0974 in Participants With Non-Dialysis Dependent Chronic Kidney Disease and Anemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 26
- 主要终点
- Incidence of treatment-emergent adverse events
研究概览
简要总结
This Phase 1b study of DISC-0974 will assess the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamics (PD) of DISC-0974 in adult participants with Non-Dialysis Dependent Chronic Kidney Disease and Anemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 years of age at the time of signing informed consent.
- •Non-dialysis-dependent chronic kidney disease, Stages 2-5, defined as eGFR <90 mL/min/1.73 m2 using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
- •Hgb <11.0 g/dL
- •Serum ferritin ≥50 μg/L at screening
- •Transferrin saturation ≤35%
- •AST and ALT <2× upper limit of normal (ULN) at screening
- •Total and direct bilirubin <ULN at screening
- •If female, then EITHER postmenopausal, defined as at least 12 months of natural, spontaneous amenorrhea and serum follicle-stimulating hormone >40 mIU/mL at screening, or at least 6 weeks following surgical menopause (bilateral oophorectomy or hysterectomy); OR agreeable to use of highly effective contraception (listed below) on Day 1 (or earlier) for at least 8 weeks after the last dose of study drug:
- •Stable hormonal contraceptive (≥3 months) in conjunction with a barrier method (eg, condom [male or female] or diaphragm)
- •Intrauterine device in place for at least 3 months
- •Tubal ligation or single male partner with vasectomy in conjunction with a barrier method (eg, condom [male or female] or diaphragm)
- •If male with female sexual partner(s) of childbearing potential, agrees to use one of the following acceptable methods of contraception during the study and for at least 8 weeks after the last study drug dose:
- •Stable hormonal contraceptive (≥3 months; female partner) in conjunction with a barrier method (eg, condom or diaphragm [female partner])
- •Intrauterine device in place for at least 3 months (female partner)
- •Surgically sterile hysterectomy, bilateral oophorectomy, or bilateral tubal ligation (female partner) in conjunction with a barrier method (eg, condom [male or female] or diaphragm)
- •Confirmed successful vasectomy in conjunction with a barrier method (eg, condom [male or female] or diaphragm)
- •Able to understand and provide written informed consent
- •Able to comply with all study procedures
排除标准
- •Treatment within 2 days prior to screening with oral iron or iron-containing supplements. Participants may be considered for the study if they undergo a 2-day washout period prior to signing the informed consent form (ICF) and screening for oral iron or iron-containing supplements. Between screening and 2 days prior to baseline visit, participants may continue oral iron or iron-containing supplements at the discretion of the Investigator, but any study-related lab draws will require a 48-hour washout from oral iron
- •Treatment within 30 days prior to screening with one of the following anemia treatments: blood transfusion, ESAs, or IV iron. Participants may be considered for the study if they undergo a 30-day washout period prior to signing the ICF and screening for erythropoietin-stimulating agents or IV iron
- •Acute dialysis or acute kidney injury within 12 weeks prior to screening or expected need to start dialysis within 24 weeks of screening
- •Hospitalization for a CV, renal, or cardiorenal condition within 30 days prior to screening
- •Positive direct antiglobulin test with reactive eluate at screening or active hemolytic anemia. This test can be performed prior to other screening procedures after the participant is consented for the prescreening testing
- •History of hereditary hemochromatosis
- •History of hemoglobinopathy or intrinsic red blood cell defect associated with anemia
- •History of total splenectomy
- •Hematopoietic stem cell or solid organ transplant within the past 10 years
- •Medical history of anemia from B12 or folate deficiency, infection, or bleeding in the 3 months prior to screening
- •Stroke, myocardial infarction, deep venous thrombosis, pulmonary or arterial embolism within 6 months prior to screening
- •If female, pregnant or breastfeeding
- •Any major surgery within 8 weeks before screening or incomplete recovery from any previous surgery
- •History of malignancy within the last 3 years. The following history/concurrent conditions are allowed: basal or squamous cell carcinoma skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical staging system). A history of completed treatment (medical or surgical) of Stage 1-2 cancers may be permitted with prior Sponsor agreement
- •Participation in any other clinical protocol or investigational study that involves administration of experimental therapy and/or therapeutic devices within 30 days of screening
- •A history or known allergic reaction to any investigational product excipients or history of anaphylaxis to any food or drug
- •History of anti-drug antibody formation
- •History of inadequately controlled heart disease (New York Heart Association Classification 3 or 4) and/or have a known left ventricular ejection fraction <35%
- •Uncontrolled fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement, despite appropriate treatment)
- •Human immunodeficiency virus positive, active hepatitis B, or active hepatitis C
- •Uncontrolled diabetes mellitus (defined as diabetes mellitus requiring initiation of insulin therapy within 3 months of screening)
- •Significant medical condition, laboratory abnormality, or psychiatric condition that would prevent the patient from participating in the study
- •Any condition or concomitant medication that would confound the ability to interpret data from the study
研究组 & 干预措施
Single Dose of Placebo
Placebo Comparator
Single dose of placebo
干预措施: Placebo (Drug)
Phase 1b Multiple Doses
Experimental
Multiple doses of DISC-0974
干预措施: DISC-0974 (Drug)
Multiple Doses of Placebo
Placebo Comparator
Multiple doses of placebo
干预措施: Placebo (Drug)
Phase 1b Single Dose
Experimental
Single dose of DISC-0974
结局指标
主要结局
Incidence of treatment-emergent adverse events
时间窗: up to 145 days
Incidence of clinically abnormal vital signs
时间窗: up to 145 days
Incidence of abnormal laboratory test results
时间窗: up to 145 days
Incidence of clinically abnormal physical exam
时间窗: up to 145 days
Incidence of clinically abnormal electrocardiograms
时间窗: up to 145 days
次要结局
- Change from baseline in concentration of iron laboratory parameter(up to 145 days)
- Change from baseline in concentration of hematologic laboratory parameters(up to 145 days)
- Cmax-Maximum drug concentration measured in plasma(up to 145 days)
- Tmax-Time of maximum drug concentration(up to 145 days)
- AUC-Area under the drug concentration time curve(up to 145 days)
- T½ - Elimination half life of the drug(up to 145 days)
- CL/F-Apparent drug clearance (only for single-dose portion)(up to 57 days)
- Vz/F; Vss/F -Apparent volume of distribution of the drug (only for single-dose portion)(up to 57 days)
研究者
研究点 (26)
Loading locations...
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