NCT04999527已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, PK and PD of DISC-0974 in Healthy Subjects Following Dose-Escalating Single Intravenous or Subcutaneous Administration
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
- 42
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This Phase 1 study of DISC-0974 will assess the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamics (PD) of DISC-0974 in adult healthy volunteers.
详细描述
Enrolled participants in this study will receive a single dose of DISC-0974 or a placebo. Samples will be collected to measure how DISC-0974 is processed by the body and how the body responds when exposed to DISC-0974. Participants will receive a single study drug dose on Day 1; and follow-up for 10 weeks (71 days). If an undetectable DISC-0974 blood concentration is observed, the duration of follow-up will be shortened to 7 days thereafter, as feasible.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female (HV only) adults aged 18 to 65 years, inclusive at the time of consent.
- •Body weight ≥50 kg and body mass index (BMI) between 18 and 33, inclusive, at Screening.
- •Systolic blood pressure ≤140 mmHg and diastolic blood pressure ≤90 at Screening.
- •No clinically significant abnormalities as determined by medical history, by results of physical examination, vital signs, ECG and lab tests at Screening.
- •QTcF <450 msec at Screening.
- •Estimated glomerular filtration rate >60 mL/min/1.73m2 based on the 4 parameter MDRD (Modification of Diet in Renal Disease) equation at Screening
- •TSAT ≤30% at Screening, as determined in a fasting morning blood sample (06:00 to 11:00 hours).
- •Hematologic parameters (red blood cell count [RBC], hemoglobin, hematocrit, platelet count, mean corpuscular volume, mean corpuscular hemoglobin concentration), serum iron, and TIBC within normal range and serum ferritin (within normal range and ≥30 ng/mL) at Screening.
- •If a male with female sexual partner(s) of childbearing potential, must agree to use acceptable methods of birth control during the study and through the End of Study (EOS) visit
- •If female, postmenopausal, as defined with at least 12 months natural, spontaneous amenorrhea, or at least 6 weeks following surgical menopause
- •Able to understand and provide written informed consent and comply with protocol requirements
排除标准
- •History of anemia or hematologic disorder within 1 year of Screening
- •History of splenectomy
- •Diagnosis or first-degree relative with a diagnosis of hemochromatosis
- •History of diabetes, cardiovascular, hepatic, renal, or malabsorptive disease
- •Vegan or iron-deficient diet within 3 months of Screening
- •Blood transfusion within 1 year of Screening
- •Whole blood donation within 6 months of Screening or plasma donation within 30 days of Screening.
- •A history of alcohol or illicit drug use disorder within 3 years of Screening, as assessed by the Investigator
- •Use of any tobacco- and/or nicotine-containing containing products, including e-cigarettes, vaping products, and nicotine replacement products, within 3 months of Screening
- •Use of multivitamin or iron supplements within 30 days prior to Screening
- •ALT or aspartate aminotransferase (AST) level above the normal range at Screening
- •Positive urine pregnancy test at Screening or Baseline (Day -1).
- •Positive serologic test for Hepatitis B surface antigen, Hepatitis C antibody, or human immunodeficiency virus (HIV) at Screening.
- •Positive urine screen for drugs of abuse or alcohol test on admission to the study center
- •Use of any systemic prescription medication within 14 days of Screening, non-iron containing dietary supplements, or non-prescription drugs within 7 days of dosing.
- •History of a major surgical procedure within 60 days of Screening or planned surgical procedure within 90 days of dosing.
- •A history or known allergic reaction to any investigational product excipients or history of anaphylaxis to any food or drug.
- •History or presence or any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions.
研究组 & 干预措施
Healthy Volunteer: Single Ascending Dose of DISC-0974
Experimental
Single Intravenous (IV) or Subcutaneous (SC) ascending dose in healthy volunteers
干预措施: DISC-0974 (Drug)
Healthy Volunteer: Single Ascending Dose of Placebo
Experimental
Single Intravenous (IV) or Subcutaneous (SC) ascending dose in healthy volunteers
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: Up to 71 days of monitoring
Incidence of abnormal laboratory test results
时间窗: Up to 71 days of monitoring
Incidence of treatment-emergent clinically abnormal electrocardiogram (ECG)
时间窗: Up to 71 days of monitoring
Incidence of treatment-emergent clinically abnormal physical exam
时间窗: Up to 71 days of monitoring
次要结局
- Plasma maximum measured drug concentration (Cmax)(Up to 71 days of testing)
- Time of maximum concentration (Tmax)(Up to 71 days of testing)
- Plasma half-life (T½)(Up to 71 days of testing)
- Area under the concentration-time curve (AUC)(Up to 71 days of testing)
研究者
研究点 (1)
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