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GSK249320A

Phase 1

Cerebrovascular Accident | Small molecule | Neurology |GSK plc|Last Updated: Jul 21, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

GSK249320A · 1 trial · 1 indication

Phase 1 1
NCT00622609Anti-MAG First Administration to HumanCerebrovascular Accident
COMPLETED46 Analytics
PHASE1COMPLETED
Anti-MAG First Administration to Human
Cerebrovascular AccidentUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of GSK249320 including: adverse events,vital signs,ECG,continuous lead II ECG monitoring,safety laboratory assessments,clinical assessment of peripheral nerve function,nerve conduction testing
Throughout study

Secondary Endpoints

Pharmacokinetic parametersAnti-GSK249320 antibody titres
At various timepoints from pre-dose to Week 52 follow-up
Pharmacokinetic parameters of ascending single IV doses of GSK249320: Cinf, AUC(0-24), AUC(0-t) and AUC(0-inf)
At various timepoints from pre-dose to Week 52 follow-up
Anti-GSK249320 Antibody titres: serum samples will be collected for anti-drug (anti-GSK249320) antibody confirmation, titration and neutralization testing
At various timepoints from pre-dose to Week 52 follow-up
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Subjects receiving GSK249320AEXPERIMENTALEligible subjects will receive escalating doses of GSK249320A in cohort 1 to 6 with a starting dose of 0.04 milligrams/kilograms up to the maximum dose of 25 milligrams/kilograms, administered as a slow intravenous infusion over 1 hour on Day 1.
Subjects receiving placeboPLACEBO_COMPARATOREligible subjects will receive single dose of sodium chloride in cohort 1 to 6, administered as a slow intravenous infusion over 1 hour on Day 1.

Interventions

NameTypeDescription
GSK249320ADRUGGSK249320A intravenous infusion will be formulated as 100 milligrams/milliliters in 2 milliliters vials (filled to 1 milliliter), in phosphate buffer and delivered by a syringe and programmable pump.
PlaceboDRUGSodium chloride intravenous infusion will be given as matching placebo.
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Healthy adult men or women of non-child bearing potential (i.e. post-menopausal or surgically sterile e.g. hysterectomy or bilateral oophorectomy). If necessary, postmenopausal status will be confirmed by serum FSH and oestradiol concentrations at screening. Surgical sterility...

Countries:United StatesAustralia
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Frequently asked questions about GSK249320A

What is GSK249320A used for?

GSK249320A is an investigational small molecule being studied for the treatment of Cerebrovascular Accident, commonly known as stroke. It is in Phase 1 clinical development and is not yet approved for any use. The drug is being developed by GSK plc.

What does GSK249320A target?

The molecular target of GSK249320A has not been disclosed in available information. As a small molecule in early development for Cerebrovascular Accident, its specific mechanism of action is not publicly detailed. The drug is being evaluated in clinical trials to determine its safety and potential efficacy.

Who makes GSK249320A?

GSK249320A is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and tolerability in patients with Cerebrovascular Accident.

What phase is GSK249320A in?

GSK249320A is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in early-stage trials to assess its safety, tolerability, and pharmacokinetics in healthy volunteers and patients.

What clinical trials is GSK249320A in?

GSK249320A has one completed Phase 1 clinical trial registered as NCT00622609, titled 'Anti-MAG First Administration to Human'. This trial enrolled 46 participants, including healthy volunteers, and was conducted in the United States and Australia. The study was placebo-controlled and randomized.

Is GSK249320A the same as Anti-MAG?

GSK249320A is associated with the trial title 'Anti-MAG First Administration to Human', but this is a descriptive name for the study, not an alternative drug name. The drug is primarily known as GSK249320A in clinical development records.