2024-517514-15-00招募中2 期
An open-label extension study evaluating the safety of zagociguat in participants with MELAS who completed TIS6463-203
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 14
- 试验地点
- 5
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
Primary Safety: To evaluate the long-term safety and tolerability of zagociguat
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form (ICF) before any study-specific procedures are performed.
- •Completed TIS6463-203 treatment through the Period 2 Week 12 visit
- •If female, meets 1 of the 2 following criteria: a. Confirmed as being postmenopausal (no menses for ≥1 year or ≥12 consecutive months) or surgically sterile (bilateral oophorectomy, hysterectomy, or tubal sterilization [tie, clip, band, or burn]) OR b. If of reproductive potential: • Is not pregnant at the time of the Screening Visit and • Has negative pregnancy test results at the Screening Visit
- •Male and female participants of reproductive potential must agree to use 1 of the following highly effective contraception methods (a or b) from the date of signing the ICF until ≥90 days after receiving their final study drug dose: a. Completely abstain from heterosexual intercourse OR b. If heterosexually active, adhere to ≥1 of the following: • Use a combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, OR intrauterine hormone-releasing system • Have had a bilateral tubal occlusion • Maintain a monogamous relationship with a partner who is permanently sterilized either by vasectomy (conducted ≥60 days before the Screening Visit or confirmed via sperm analysis), hysterectomy, bilateral salpingectomy, or bilateral oophorectomy or is sterile due to postmenopausal status.
- •Female participants on hormone replacement therapy must use ≥1 nonhormonal highly effective contraception methods listed above
- •Male participants must agree to refrain from donating sperm from the Screening Visit through 90 days after their final dose of study drug
- •Female participants must agree to refrain from egg donation through 30 days after the final dose of study drug
排除标准
- •Any medical condition or clinical finding that, per investigator judgement, would preclude safe study participation and/or completion of all trial requirements
研究组 & 干预措施
zagociguat 15 mg
Experimental
Participants receiving zagociguat 15 mg
干预措施: zagociguat 15 mg (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events (TEAEs)
次要结局
- Vital sign measurements, ECG assessments, clinical laboratory tests, and C-SSRS responses at each scheduled timepoint
- DEXA hip and lumbar spine BMD at each scheduled timepoint
- Concentrations of CTX and P1NP at each scheduled timepoint
- Incidence of SLE. Time to first SLE from Day 1
- NMDAS item scores at each scheduled timepoint
- Concentrations of lactate, GDF-15, FGF-21, B2M, serum amyloid P component, TNFR-2, vWF, ICAM-1, NfL, and VCAM-1 at each scheduled timepoint
- CGI-C overall MELAS scale score at each scheduled timepoint
- eGFR and UACR at each scheduled timepoint
- HbA1c level at each scheduled timepoint
- Concentrations of troponin I, NT-proBNP, and creatine kinase (CK)-MB at each scheduled timepoint
- Exploratory pharmacokinetics: Concentrations of zagociguat at each scheduled time point
研究者
Clinical Operations
Scientific
Tisento Therapeutics Inc.
研究点 (5)
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