NCT03038633已完成1 期
A Trial to Evaluate the Safety and Tolerability of a Novel Medical Food for Management of Iron Deficiency Anemia
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity, (DLT)
研究概览
简要总结
This is a Phase 1 clinical trial designed to evaluate the safety and tolerability of a novel medical food utilizing a nutritional strain of yeast for management of Iron Deficiency Anemia.
详细描述
The investigational product is a medical food and is the result of discoveries following extensive research on two preclinical models carried out by a team of researchers at Penn State University. This study will utilize the standard "3+3" rule-based dose-escalation schemes, which use predetermined dose levels and cohorts of three patients. The total time commitment for each subject is approximately three months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemoglobin, (Hgb) 7-10 g/dL; transferrin saturation <20%; and serum ferritin <20ng/mL
排除标准
- •Pregnant or sexually-active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception (tubal ligation or otherwise be incapable of pregnancy, hormonal contraceptives, spermicide plus barrier or intrauterine device).
- •Present consumption of iron supplements or multivitamins must be switched to vitamins not containing iron, such as the multivitamin Centrum Silver. No washout period is necessary since it will be apparent from the ongoing anemia that any current supplements are ineffective.
- •Current anemia not attributed to immune deficiency, (ID) (e.g. other microcytic anemia or hemolytic, macrocytic, sideroblastic or myelosuppression or chemotherapy or radiotherapy induced anemia).
- •Active malignancy within 1 year. Basal or squamous cell skin cancer is not exclusionary.
- •Aspartate Aminotransferase, (AST) or Alanine Aminotransferase, (ALT) at screening greater than 1.5 times the upper limit of normal.
- •Known positive hepatitis B with evidence of active hepatitis.
- •Known positive HIV-1/HIV-2 antibodies (anti-HIV).
- •Patient has a current diagnosis of asthma and is actively using an anti-asthmatic therapy.
- •Received an investigational drug within 30 days of screening.
- •Hemochromatosis or other iron storage disorders.
- •Unregulated hypertension
- •Chronic kidney disease.
- •Chronic inflammatory condition including but not limited to Lupus and Rheumatoid Arthritis.
- •Significant cardiovascular disease, including but not limited to myocardial infarction or unstable angina within 6 months prior to study inclusion or current history of New York Heart Association, (NYHA) Class III or IV congestive heart failure.
- •Irritable Bowel Syndrome
- •Any other laboratory abnormality, medical condition or psychiatric disorder which in the opinion of the investigator puts the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
- •Breastfeeding planned on or after enrolling in the study.
- •Known allergy to yeast
- •Currently on Monoamine oxidase inhibitors, (MAOI's) or Demerol
研究组 & 干预措施
Cohort 1
Experimental
900 mg novel medical food containing 22.2mg iron
- receive 900 mg by mouth (3 capsules, one at each meal) daily; after Day 28 remain on level for additional 2 months if clinically indicated
- receive a phone call from coordinator between Day 5-9 to assess side effects and medications
- return to General Clinical Research Center, (GCRC) for a blood draw at days 14, 28, 60, and 90 while on novel medical food
干预措施: Novel Medical Food (Other)
Cohort 2
Experimental
1800 mg novel medical food containing 44.4 mg of iron
- receive 1800 mg by mouth (3 capsules, one at each meal) daily; after Day 28 remain on level for additional 2 months if clinically indicated
- receive a phone call from coordinator between Day 5-9 to assess side effects and medications
- return to GCRC for a blood draw at days 14, 28, 60, and 90 while on novel medical food
干预措施: Novel Medical Food (Other)
Cohort 3
Experimental
2700 mg novel medical food containing 66.6 mg of iron
- receive 2700 mg by mouth (3 capsules, one at each meal) daily; after Day 28 remain on level for additional 2 months if clinically indicated
- receive a phone call from coordinator between Day 5-9 to assess side effects and medications
- return to GCRC for a blood draw at days 14, 28, 60, and 90 while on novel medical food
干预措施: Novel Medical Food (Other)
Cohort 4
Experimental
3600 mg novel medical food containing 88.8 mg of iron
- receive 3600 mg by mouth (3 capsules, one at each meal) daily; after Day 28 remain on level for additional 2 months if clinically indicated
- receive a phone call from coordinator between Day 5-9 to assess side effects and medications
- return to GCRC for a blood draw at days 14, 28, 60, and 90 while on novel medical food
干预措施: Novel Medical Food (Other)
结局指标
主要结局
Dose-limiting toxicity, (DLT)
时间窗: 28 Days
Still evaluating data
次要结局
未报告次要终点
研究者
Jeffrey J. Pu, MD, PhD
Assistant Proffesor of Medicine
Milton S. Hershey Medical Center
研究点 (1)
Loading locations...
相似试验
招募中
1 期
The Safety, Tolerability and Efficacy of NouvNeu001 for Parkinson's DiseaseParkinson DiseaseNCT06167681iRegene Therapeutics Co., Ltd.40
已完成
1 期
PE0116 Injection in Treatment of Patients With Advanced Solid TumoursLocally Advanced/Metastatic Solid TumorsNCT05800249Shanghai HyaMab Biotech Co.,Ltd.31
招募中
1 期
A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia (CARDINAL)Chronic Myeloid Leukemia, Chronic PhaseChronic Myeloid LeukemiaNCT06163430Terns, Inc.180
招募中
1 期
A Phase I Study of CFT8919 in Patients With Advanced NSCLCNon-Small Cell Lung Cancer With EGFR MutationNCT06641609Betta Pharmaceuticals Co., Ltd.166
进行中（未招募）
1 期
Clinical Trial of SARS-CoV-2 mRNA Vaccine in ChinaCOVID-19NCT05364047AIM Vaccine Co., Ltd.144