NCT01694381 is a EARLY_PHASE1 clinical trial of M5 in Acute Ischemic Stroke, sponsored by TSI, LLC.

Who is sponsoring NCT01694381?

NCT01694381 is sponsored by TSI, LLC.

What drugs are being tested in NCT01694381?

Interventions in NCT01694381: M5, C1-inhibitor.

What condition does NCT01694381 study?

NCT01694381 studies Acute Ischemic Stroke.

Is NCT01694381 still recruiting?

NCT01694381 is currently terminated. Last updated 14 January 2021.

Last reviewed 2021-01-14 · How we verify

NCT01694381

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase 1 Trial of Mutant proUK, M5, and Its Inhibitor, C1-inhibitor

Terminated EARLY_PHASE1 Last updated 14 January 2021

What this trial tests

EARLY_PHASE1 trial testing M5 in Acute Ischemic Stroke in 8 participants. Terminated before completion.

Timeline

1 September 2012

Primary endpoint
1 October 2012

1 October 2012

Quick facts

Lead sponsor	TSI, LLC
Phase	EARLY_PHASE1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	8
Start date	1 September 2012
Primary completion	1 October 2012
Estimated completion	1 October 2012
Sites	1 location across Netherlands

Drugs / interventions tested

M5 — full drug profile →
C1-inhibitor — full drug profile →

Conditions studied

Acute Ischemic Stroke — all drugs for Acute Ischemic Stroke →

Sponsor

TSI, LLC — full company profile →

Who can join

Adults 18 to 35, male only, with Acute Ischemic Stroke. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Changes to vital signs, routine safety laboratory results, or ECG-findings
Time frame: -42d, -14h, -15', 15', 30', 45',60', 90', 10h, 24h, 48h, 7d

Sponsor's own description

Single-chain urokinase-type plasminogen activator (pro-urokinase) is a highly effective thrombolytic drug. At pharmacologic concentrations however, pro-urokinase is converted to urokinase - a non specific thrombolytic, limiting its therapeutic use. Mutant pro-urokinase (M5) is more stable and its conversion to urokinase is inhibited by C1-inhibitor. The primary objectives of the study are: * To assess the overall safety and tolerability related to systemic plasminogen activation of single doses of M5 over a wide dose range (study part I). * To assess the effect of single doses of C1-inhibitor on the overall safety and tolerability of single doses of M5 and its effect on M5-induced coagulation changes (study part II).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Ischemic stroke: From pathological mechanisms to neuroprotective strategies.
Jiang Y, Liu Z, Liao Y, Sun S, et al · · 2022 · cited 35× · PMID 36438975 · DOI 10.3389/fneur.2022.1013083

Verify or expand the search:

Other recruiting trials for Acute Ischemic Stroke

Currently open trials in the same condition.

NCT07115940 — Medical Management With Endovascular Thrombectomy Versus Medical Management Alone in Patients Presenting Beyond 24 Hours · NA · recruiting
NCT07404852 — Non-invasive Vagus Nerve Stimulation to Reduce Inflammation and Brain Injury Blood Biomarkers Following an Acute Ischemi · NA · recruiting
NCT07361302 — A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Pe · Phase 3 · recruiting
NCT07436156 — SUMMIT RISE Study of Acute Ischemic Stroke Patients · Phase 4 · recruiting
NCT07203625 — Tenecteplase Before Interhospital Transfer in Acute Basilar Artery Occlusion at 4.5 to 24 Hours · Phase 4 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01694381 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by TSI, LLC
Last refreshed: 14 January 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01694381.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing