2023-509432-25-00招募中2 期
STS-001: An explorative clinical study to assess the potential of intravenously administered sodium thiosulfate in subjects with primary Raynaud’s phenomenon
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- For each treatment:area under the cooling and rewarming curve (AUC) and mean ischemic time of one hand assessed by cooling and recovery photo-electric plethysmography (PPG, BIOPAC)
研究概览
简要总结
To determine the effect of increasing doses of intravenously administered STS on the magnitude of vasodilatation in subjects with Raynaud’s phenomenon
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks) and grapefruit (juice) from 48 hours (2 days) prior to each admission to the clinical research center
- •Diagnosed with primary Raynaud’s phenomenon
- •Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
- •Female or male
- •No clinically significant abnormality on 12-lead ECG performed at screening
- •Willing to comply with all study related procedures and restrictions;
- •Subject is a non-smoker or previous smoker who stopped smoking more than 3 months ago;
- •Subjects must have an estimated glomerular filtration rate (eGFR) corrected for their body surface area of ≥90 mL/min based on the CKD-EPI equation, with a single repeat permitted to assess eligibility, if needed;
- •All prescribed medication (except for oral contraceptives) must have been stopped at least 14 days prior to each admission to the clinical research center
- •Ability and willingness to abstain from alcohol from 48 hours (2 days) prior to screening and each admission to the clinical research center
排除标准
- •In case of females, subject is pregnant or breast feeding
- •Subject has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 3 months prior to the screening visit
- •Unsuitable veins for blood sampling;
- •Significant and/or acute illness within 5 days prior to drug administration that may impact safety assessments, in the opinion of the Investigator
- •Presence of abnormal capillary microscopy or other structural vascular abnormalities of forearm, hands, and fingers;
- •Patients with concomitant cardiovascular disease like hypertension and previous cerebrovascular events
- •Asthma patients
- •Presence of auto-antibodies associated with secondary causes of Raynaud’s phenomenon;
- •Any secondary disease associated with Raynaud’s phenomenon i.e. systemic autoimmune disease, other structural vascular or systemic diseases associated with Raynaud’s;
- •Any invasive radiological, anesthesiologic or surgical procedure performed for Raynaud’s phenomenon
- •History of digital ulcers
- •History of severe trauma to forearm, hands and fingers
- •Subject is mentally or legally incapacitated, has significant emotional problems at the time of screening visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder over the last year;
- •Subject is unable to refrain from or anticipates the use of any medication throughout the study
- •Subject consumes excessive amounts of alcohol, defined as greater than 21 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer (284 mL), wine (125 mL), or distilled spirits (25 mL) per week;
结局指标
主要结局
For each treatment:area under the cooling and rewarming curve (AUC) and mean ischemic time of one hand assessed by cooling and recovery photo-electric plethysmography (PPG, BIOPAC)
For each treatment:area under the cooling and rewarming curve (AUC) and mean ischemic time of one hand assessed by cooling and recovery photo-electric plethysmography (PPG, BIOPAC)
For each treatment: regions of interest peripheral blood perfusion of same hand by FLIR thermography system (FLIR E53)
For each treatment: regions of interest peripheral blood perfusion of same hand by FLIR thermography system (FLIR E53)
次要结局
- Pharmacokinetics: Determination and comparison of AUC0-t, AUC0-inf Cmax after increasing dose regimens of intravenously administered STS
- Pharmacokinetics: Determination and comparison of steady-state levels after increasing dose regimens of intravenously administered STS
- Pharmacokinetics: Determination and comparison of elimination PK parameters after increasing dose regimens of intravenously administered STS
- Pharmacokinetics: Determination of endogenous STS levels (based on various pre-dose levels) in Raynaud’s patients
- Safety and tolerability as evidenced by: Incidence of treatment-emergent adverse events (TEAEs)
- Safety and tolerability as evidenced by: ECG
- Safety and tolerability as evidenced by: Continuous blood pressure measurement (Finapress)
- Safety and tolerability as evidenced by: Local tolerability at vein of intravenous administration
- Pharmacodynamics: Oxidative stress (systemic free thiols, plasma malondialdehyde (MDA))
- Pharmacodynamics: Inflammation (circulating pro-inflammatory cytokines e.g. IL-6, IL-1 beta and TNFalpha)
- Pharmacodynamics: Endothelial activation (circulating adhesion molecules)
研究者
dr. Udo Mulder
Scientific
Universitair Medisch Centrum Groningen
研究点 (1)
Loading locations...
相似试验
已完成
1 期
QTc Assessment in a Single-Dose Study of Hydronidone CapsulesHepatic FibrosisNCT07263152Beijing Continent Pharmaceutical Co, Ltd.48
招募中
1 期
A Study of Lutetium [177Lu]-BL-ARC001 in Patients With Locally Advanced or Metastatic Lung Cancer, Breast Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid TumorsBreast CancerLung CancerNCT07274852Sichuan Baili Pharmaceutical Co., Ltd.22
已完成
4 期
This is a study to evaluate dose-flexibility of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis2023-504869-23-00AbbVie Deutschland GmbH & Co. KG272
招募中
2 期
Study that aims to investigate how effective and safe the use of a novel modified release tablet formulation of Colesevelam hydrochloride-MMX is for patients with idiopathic bile acid diarrhoea (BAD), randomly allocated to 2 different dose regimens of the active product or to the inactive placebo formulation.2024-511993-55-00Cosmo Technologies Limited120
撤回
4 期
A multicentre randomised study on percutaneous stellate ganglion block as first-line treatment in patients with electrical storm: the STAR 2 study2024-520387-34-00Fondazione IRCCS Policlinico San Matteo180