SODIUM THIOSULFATE PENTAHYDRATE for Primary Raynaud's phenomenon

Inclusion criteria

• {"criterion_text":"- Age 18-45"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Diagnosed with primary Raynaud’s phenomenon"}
• {"criterion_text":"- Subject understands the study procedures and agrees to participate in the study by giving written informed consent."}
• {"criterion_text":"- Female or male"}
• {"criterion_text":"- No clinically significant abnormality on 12-lead ECG performed at screening"}
• {"criterion_text":"- Willing to comply with all study related procedures and restrictions;"}
• {"criterion_text":"- Subject is a non-smoker or previous smoker who stopped smoking more than 3 months ago;"}
• {"criterion_text":"- 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;"}
• {"criterion_text":"- All prescribed medication (except for oral contraceptives) must have been stopped at least 14 days prior to each admission to the clinical research center"}
• {"criterion_text":"- Ability and willingness to abstain from alcohol from 48 hours (2 days) prior to screening and each admission to the clinical research center"}

Exclusion criteria

• {"criterion_text":"- In case of females, subject is pregnant or breast feeding"}
• {"criterion_text":"- Subject has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 3 months prior to the screening visit"}
• {"criterion_text":"- Unsuitable veins for blood sampling;"}
• {"criterion_text":"- Significant and/or acute illness within 5 days prior to drug administration that may impact safety assessments, in the opinion of the Investigator"}
• {"criterion_text":"- Presence of abnormal capillary microscopy or other structural vascular abnormalities of forearm, hands, and fingers;"}
• {"criterion_text":"- Patients with concomitant cardiovascular disease like hypertension and previous cerebrovascular events"}
• {"criterion_text":"- Asthma patients"}
• {"criterion_text":"- Presence of auto-antibodies associated with secondary causes of Raynaud’s phenomenon;"}
• {"criterion_text":"- Any secondary disease associated with Raynaud’s phenomenon i.e. systemic autoimmune disease, other structural vascular or systemic diseases associated with Raynaud’s;"}
• {"criterion_text":"- Any invasive radiological, anesthesiologic or surgical procedure performed for Raynaud’s phenomenon"}
• {"criterion_text":"- History of digital ulcers"}
• {"criterion_text":"- History of severe trauma to forearm, hands and fingers"}
• {"criterion_text":"- 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;"}
• {"criterion_text":"- Subject is unable to refrain from or anticipates the use of any medication throughout the study"}
• {"criterion_text":"- 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;"}

Primary endpoints

• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Assessed by cooling and recovery photo-electric plethysmography (PPG, BIOPAC); measurement of area under cooling and rewarming curve (AUC) and mean ischemic time of one hand."}
• {"endpoint_text":"- For each treatment: regions of interest peripheral blood perfusion of same hand by FLIR thermography system (FLIR E53)","definition_or_measurement_approach":"Measured using FLIR thermography system (FLIR E53) to assess peripheral blood perfusion in regions of interest of the same hand."}

Secondary endpoints

• {"endpoint_text":"- Pharmacokinetics: Determination and comparison of AUC0-t, AUC0-inf Cmax after increasing dose regimens of intravenously administered STS","definition_or_measurement_approach":"PK parameters AUC0-t, AUC0-inf and Cmax measured following increasing IV dose regimens of STS."}
• {"endpoint_text":"- Pharmacokinetics: Determination and comparison of steady-state levels after increasing dose regimens of intravenously administered STS","definition_or_measurement_approach":"Assessment and comparison of steady-state concentrations following increasing IV STS dose regimens."}
• {"endpoint_text":"- Pharmacokinetics: Determination and comparison of elimination PK parameters after increasing dose regimens of intravenously administered STS","definition_or_measurement_approach":"Measurement and comparison of elimination PK parameters after increasing IV dose regimens."}
• {"endpoint_text":"- Pharmacokinetics: Determination of endogenous STS levels (based on various pre-dose levels) in Raynaud’s patients","definition_or_measurement_approach":"Measurement of endogenous STS pre-dose levels in patients."}
• {"endpoint_text":"- Safety and tolerability as evidenced by: Incidence of treatment-emergent adverse events (TEAEs)","definition_or_measurement_approach":"Recording incidence of TEAEs during the study."}
• {"endpoint_text":"- Safety and tolerability as evidenced by: ECG","definition_or_measurement_approach":"ECG monitoring to assess safety and tolerability."}
• {"endpoint_text":"- Safety and tolerability as evidenced by: Continuous blood pressure measurement (Finapress)","definition_or_measurement_approach":"Continuous BP measurement using Finapress device."}
• {"endpoint_text":"- Safety and tolerability as evidenced by: Local tolerability at vein of intravenous administration","definition_or_measurement_approach":"Assessment of local tolerability at IV administration site."}
• {"endpoint_text":"- Pharmacodynamics: Oxidative stress (systemic free thiols, plasma malondialdehyde (MDA))","definition_or_measurement_approach":"Measurement of systemic free thiols and plasma MDA as oxidative stress biomarkers."}
• {"endpoint_text":"- Pharmacodynamics: Inflammation (circulating pro-inflammatory cytokines e.g. IL-6, IL-1 beta and TNFalpha)","definition_or_measurement_approach":"Measurement of circulating pro-inflammatory cytokines such as IL-6, IL-1 beta and TNF-alpha."}
• {"endpoint_text":"- Pharmacodynamics: Endothelial activation (circulating adhesion molecules)","definition_or_measurement_approach":"Measurement of circulating adhesion molecules indicative of endothelial activation."}

Netherlands

Earliest CTIS Part Ii Submission Date

16-09-2025

Latest Decision Or Authorization Date

19-12-2025

Processing Time Days

94

Number Of Sites

1

Number Of Participants

12

Primary sponsor

Full Name

Universitair Medisch Centrum Groningen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"TS Vascular BV","duties_or_roles":"Monetary support","organisation_type":""}