NCT06560762招募中1 期
A Phase 1, Open Label, Multiple Ascending Dose Study to Assess Safety and Tolerability of STM-01 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Secretome Therapeutics2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年3月3日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Frequency, grade and relationship to STM-01 of unsolicited local and systemic AEs (any SAEs, MAAEs and AESIs ) during the 60-d follow-up period post IV infusion at D0 and D28 per the CTCAE v5.0 and clinical-safety laboratory parameters up to D 56.
研究概览
简要总结
A Phase 1, Open label, Multiple Ascending Dose Study to Assess Safety and Tolerability of STM-01 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Stable New York Heart Association (NYHA) Class II or III HF diagnosis, evident at least 6 months prior to enrolment as confirmed by medical history.
- •Documented prior objective evidence of heart failure
- •Screening ejection fraction ≥50%.
- •Adequate bone marrow reserve and organ function at the Screening
- •Receiving standard of care heart failure therapy at stable doses for at least 30 days prior to Screening.
排除标准
- •Participant in any other study and has received any other investigational drug within 30 days prior to screening or 5-half-lives, whichever is longer, or any other investigational implanted device within 30 days prior to screening, or are taking part in a nonmedication study which, in the opinion of the Investigator, would interfere with study compliance or outcome assessments.
- •Prior diagnosis of hypertrophic cardiomyopathy or a known infiltrative or storage disorder causing HFpEF and/or cardiac hypertrophy, such as amyloidosis, Fabry disease, or Noonan syndrome with LV hypertrophy.
- •Persistent or permanent atrial fibrillation and is not therapeutically anticoagulated for at least the 4 weeks prior to the initial screening visit or is not adequately rate controlled within 6 months prior to informed consent according to investigator discretion.
- •Other medical or psychiatric conditions that, in the opinion of the Investigator, would preclude obtaining voluntary consent/assent or would confound the objectives of the study.
研究组 & 干预措施
Dose arm (2 cohorts; 2 doses)
Other
Up to 12 participants will be enrolled (Up to 6 participants, for 5 completers per cohort). Each successive cohort of participants will receive STM-01 at the following doses: 100.0 x 106 nMSCs, and 200.0 x 106 nMSCs.
干预措施: STM01 (Drug)
结局指标
主要结局
Frequency, grade and relationship to STM-01 of unsolicited local and systemic AEs (any SAEs, MAAEs and AESIs ) during the 60-d follow-up period post IV infusion at D0 and D28 per the CTCAE v5.0 and clinical-safety laboratory parameters up to D 56.
时间窗: Dose 1 (Day 0) till end of study (Day 56)
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Safety and Tolerability of IMM01-STEM in Patients With Muscle Atrophy Related to Knee Osteoarthritis.Muscle AtrophyNCT05211986Immunis, Inc.13
已完成
1 期
Safety and Tolerability of MS-R001 in Patients With Diabetic Macular Edema Secondary to Diabetic RetinopathyDiabetic Macular EdemaDiabetic RetinopathyNCT00401115Santen Inc.50
已完成
1 期
Effects of STM 434 Alone or in Combination With Liposomal Doxorubicin in Patients With Ovarian Cancer or Other Advanced Solid TumorsFallopian Tube CancerEndometrial CancerSolid TumorsOvarian CancerNCT02262455Santa Maria Biotherapeutics32
已完成
1 期
Study of TAK-901 in Adults With Advanced Solid Tumors or LymphomaAdvanced Solid TumorsLymphomaNCT00935844Millennium Pharmaceuticals, Inc.20
已完成
1 期
SAD of IVT VP-001 in PRPF31 Mutation-Associated Retinal Dystrophy SubjectsRetinal DystrophyPRPF31 Mutationassociated Retinal DystrophyRP11NCT05902962PYC Therapeutics17