Phase 2 Stroke Trial, Recruiting NCT07581210 Sponsor: Shanghai QuietD Biotechnology Co., Ltd. Condition: Stroke
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Phase 2 Stroke Trial, Recruiting

NCT07581210
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 to 85 years old, of any gender
  • People who have been diagnosed with an acute ischemic stroke (a stroke caused by a blocked blood vessel in the brain) according to 2023 Chinese stroke diagnosis guidelines
  • People whose stroke symptoms began no more than 24 hours ago (if the exact time is unknown — for example, if the stroke happened during sleep — the last time the person was known to be well is used as the starting point)
  • People who were largely independent in daily life before the stroke, with little to no disability (a score of 0 or 1 on a standard disability scale called the modified Rankin Scale)
  • People whose stroke symptoms fall within a moderate severity range on a standard stroke assessment scale (NIHSS score between 6 and 20), and who have measurable weakness in both an arm and a leg
  • People who are planned to receive, or have already received, clot-dissolving treatment (thrombolysis) for their stroke
  • Women of childbearing potential who have a negative pregnancy test and report no sexual activity in the 14 days before joining the study, and all people of childbearing potential (male or female) who agree not to plan a pregnancy or donate sperm during the study and are willing to use at least one reliable form of contraception
  • People (or their legal guardian) who are willing and able to provide signed consent to participate

Who may not be able to join:

  • People with a known allergy to any ingredient in the study drug (QD202) or its placebo
  • People whose brain scan shows any bleeding in the brain, such as a bleed around or within the brain — though people with only very small, minor bleeds (microbleeds) or bleeding that occurs as a complication of clot-dissolving treatment may be considered at the trial doctor's discretion
  • People whose stroke turns out to be a transient ischemic attack (TIA), sometimes called a "mini-stroke," where symptoms resolve quickly
  • People with poorly controlled blood pressure despite active treatment — either very high (top number at or above 220 or bottom number at or above 120 mmHg) or very low (top number at or below 90 or bottom number at or below 40 mmHg)
  • People with severely abnormal blood sugar levels — either very high (at or above 400 mg/dL) or very low (at or below 50 mg/dL)
  • People with a heart rate that is too slow (below 50 beats per minute) or too fast (above 120 beats per minute), certain types of heart rhythm problems, or a history within the past 6 months of serious heart conditions including severe heart failure, unstable chest pain, heart attack, or serious irregular heartbeat
  • People who are deeply unconscious or very severely unresponsive at the time of assessment before clot-dissolving treatment (a score of 2 or higher on the consciousness section of the stroke severity scale)
  • People with a history of severe mental illness or severe dementia
  • People with a history of depression or anxiety, if the trial doctor considers participation to be inappropriate
  • People who are not suitable for clot-dissolving treatment, or who have had or are planned to have a procedure to physically remove or break up the clot inside a blood vessel (endovascular therapy)
  • People who have taken certain brain-protective medications after the stroke began, including a specific list of named drugs (confirm with trial site for the full list) — mannitol used to lower pressure in the brain is an exception and is permitted
  • People who have been diagnosed with cancer and are currently receiving anti-cancer treatment
  • People with a serious ongoing medical condition where life expectancy is estimated to be less than 90 days
  • People with severe active liver disease (such as hepatitis or cirrhosis) or abnormal liver blood test results more than twice the normal upper limit
  • People with severe active kidney disease or significantly reduced kidney function (eGFR below 60 mL/min/1.73 m²)
  • People with a tendency to bleed, including a low platelet count (below 75.0×10⁹/L), or a history of major bleeding in the 3 months before the stroke
  • People who have had major surgery within 4 weeks before joining the study, if the trial doctor believes this could affect the study assessments or the person's survival over 90 days
  • People with alcohol dependence, drug abuse, or substance addiction
  • People who have taken part in another clinical trial involving an experimental drug, vaccine, or medical device within the past 3 months
  • People who cannot safely have a CT or MRI scan, for example due to a pacemaker, certain metal implants, or severe claustrophobia
  • People with an allergy to contrast dye used in medical scans
  • People with chronic moderate to severe lung or breathing disease
  • People who are pregnant or breastfeeding
  • People whom the trial doctor considers unsuitable for any other reason

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 86-13524815449

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Shanghai QuietD Biotechnology Co., Ltd.
Registry
ClinicalTrials.gov
Start date
14 October 2025
Est. completion
1 August 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Safety and Tolerance

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov