CTIS2023-505995-31-00招募中1 期
A Phase 1/2, First-in-Human, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HMB-001 in Participants With Glanzmann Thrombasthenia - HMB-001-CL101
Hemab ApS0 个研究点目标入组 41 人开始时间: 2023年10月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 41
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 64（—）
- 性别
- All
入选标准
- •1. Part A • Each participant in Part A must meet the following inclusion criteria to be eligible for enrolment in the study: Age 18 to 65 years, inclusive, at the time of signing informed consent. Glanzmann thrombasthenia; documented abnormal, diagnostic platelet aggregometry plus deficiency of the aIIbß3 (GPIIb/GPIIIa) receptor via flow cytometry; or genetic diagnosis. Has not received a COVID-19 vaccine dose in the last 28 days. Has not received any live vaccine within 4 weeks of enrollment and is not planning to have a live vaccine during the study period. Agrees not to receive COVID-19 vaccination throughout the dosing period and for 4 weeks after the final dose. Has the ability to provide informed consent to participate in the trial, in accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 (R2) (2016) and applicable regulations, before completing any trial-related procedures. Has an understanding, ability, and willingness to fully comply with trial procedures and restrictions. Vital signs are within the following ranges at Screening: Supine heart rate = 105 bpm (after at least 5 minutes of supine rest). Blood pressure (BP): Supine BP (after at least 5 minutes of supine rest or based on 24 hours monitor demonstrating normotensive BP): Systolic blood pressure: 90 – 140 mmHg. Diastolic blood pressure: 40 – 90 mmHg. Women of child-bearing potential have a negative serum pregnancy test within 72 hours prior to the first dose of HMB001. Women of child-bearing potential agree to use highly effective contraceptive methods (excluding estrogen-containing combined oral contraceptive pill; see Section 13.1) as per exclusion criteria and avoid egg donation for 14 days prior to Day 1, during the study treatment, and for 6 months after the last dose of HMB001. A woman is considered to be of child-bearing potential unless she: has had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy; is age > 50 years and has been amenorrhoeic for = 12 months (including no irregular menses or spotting) in the absence of any medication which induces a menopausal state and has documented ovarian failure by follicle-stimulating hormone levels within the institutional laboratory postmenopausal range). Men of child-producing potential agree to use highly effective contraceptive methods (see Section 13.1) and avoid sperm donation for 14 days prior to Day 1, during the study treatment, and for 6 months after the last dose of HMB001. A man is considered to be of child-producing potential unless he has had a bilateral vasectomy with documented aspermia or a bilateral orchiectomy. Participants must meet the following baseline organ function, indicated by laboratory criteria: Evidence of no greater than mild to moderate reduction in renal function (stage 3a kidney disease), measured by an estimated glomerular filtration rate (eGFR) of =45 ml/min/1.73m2 at Screening. An aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin = 1.5 upper limit of normal (ULN) range at Screening. For participants with a history of Gilbert’s Syndrome, total bilirubin = 2 × ULN at Screening. Note: Where a participant exceeds any of the criteria in (b), they may undergo additional safety assessment by a board certified hepatologist, if the findings are subsequently deemed to be non-clinically significant, these results will not prevent the participant’s inclusion. Hemoglobin >85 g/L and platelet
排除标准
- •1. Part A • Each participant in Part A must not meet any of the following exclusion criteria to be eligible for enrolment in the study: Severe infection or inflammation at the time of Screening. History of clinically significant hypersensitivity associated with monoclonal antibody therapies. Personal history of venous or arterial thrombosis or thromboembolic disease, with the exception of catheter-associated, mild thrombophlebitis events. Known severe congenital or acquired thrombophilia. Has a positive test for Hepatitis B surface antigen (HbsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at Screening with RNA level above the lower limit of detection. Participants with a positive test for HCV Ab may be included if they have a negative RNA test, consistent with cleared infection. Participants with an HIV RNA level lower than the limit of detection may be included. Is positive for COVID-19 based on lateral flow or PCR within 48 hours prior to the first dose or had a known COVID-19 infection confirmed by lateral flow or PCR within 6 weeks prior to the first dose of HMB-001. Other conditions that substantially increase risk of thrombosis by the discretion of the investigator including, but not limited to: significant family history, body mass index (BMI) >30 kg/m2 (moderately obese, adjusted for ethnicity), reduced mobility, active malignancy, major surgery within 6 weeks preceding first dose of HMB-001, post-partum within 12 weeks preceding first dose of HMB-001. Women who are using estrogen-containing medication or hormone modulators (within 8 weeks pre-dose to 8 weeks post-dose of HMB-001) including: Combined oral contraception pill. Hormone replacement therapy (excluding transdermal patches). Estrogen receptor modulators (e.g., Tamoxifen). Gonadotropin releasing hormone receptor (GnRH receptor) agonist. Clinically significant cardiovascular disease including, but not limited to: New York Heart Association Class III or IV heart failure, coronary artery disease, uncontrolled arrythmia, moderate to severe valvular heart disease, peripheral vascular disease, and ischemic stroke. Other conditions that substantially increase the risk of cardiovascular events by the discretion of the Investigator including, but not limited to: smoking, cocaine use, and uncontrolled hypertension. Congenital or acquired bleeding disorders other than Glanzmann thrombasthenia. Concurrent disease, treatment, medication, or abnormality in clinical laboratory tests that may pose additional risk in the opinion of the investigator and preclude the participant’s safe participation in and completion of the study. Addiction or other diseases that prevent the participant from appropriately assessing the nature and scope of the clinical study or participating in study procedures by the discretion of the Investigator. Received investigational medication in another clinical study within 5 half-lives before administration of HMB-001. Female participants who are pregnant (including a positive serum pregnancy test at Screening) or breastfeeding. Participants who initially failed due to temporary non-medically significant issues are eligible for re-screening once the cause has resolved., 2. Part B • Each participant in Part B must not meet any of the following exclusion criteria to be eligible for enrolment in the study: Active severe infection or inflammation at the time of Screening or prior to the first dose of HMB-001. History of cl
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