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GSK933776 for SQ administration

Phase 1

Atrophy, Geographic | Small molecule | Ophthalmology |GSK plc|Last Updated: May 15, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

GSK933776 for SQ administration · 1 trial · 1 indication

Phase 1 1
NCT02033668Pharmacokinetic (PK) Study of GSK933776 in Healthy VolunteersAtrophy, Geographic
COMPLETED36 Analytics
PHASE1COMPLETED
Pharmacokinetic (PK) Study of GSK933776 in Healthy Volunteers
Atrophy, GeographicUnlock trial analytics

Study Endpoints

Primary Endpoints

Relative bioavailability of GSK933776 after single dose SQ or IM administration as compared to IV infusion
Blood samples will be collected at following time points: pre-dose and at (0.25, 0.5, 0.75, 1, 2, 4 hours only for IV infusion), 6, 24, 48, 72, 96, 120, 216, 336, 504, 672, 1344 and 2016 hours post dose

Bioavailability is defined as the rate and extent to which drug reaches the systemic circulation. The relative bioavailability will be calculated from the ratio of area under concentration time curve from time zero to infinity (AUC \[0-infinity\]) following single dose SQ and IM injection to intravenous (IV) infusion

Relative bioavailability of GSK933776 after repeat dose SQ administration as compared to IV infusion
Blood samples will be collected at following time points: pre-dose, 6, 24, 48, 72, 96 and 120 hours post dose in each of the 4 dosing weeks and additionally at 216, 336, 504, 672, 1344 and 2016 hours post last dose

Bioavailability is defined as the rate and extent to which drug reaches the systemic circulation. The relative bioavailability will be calculated from the ratio of AUC (0-infinity) following SQ repeat dose injections to intravenous (IV) infusion

Secondary Endpoints

Composite of PK parameters of GSK933776 following single dose IM and SQ administration as compared to IV administration
Samples will be collected at following time points: pre-dose and at (0.25, 0.5, 0.75, 1, 2, 4 hours only for IV infusion), 6, 24, 48, 72, 96, 120, 216, 336, 504, 672, 1344 and 2016 hours post dose
Composite of PK parameters of GSK933776 following repeat dose SQ administration as compared to IV administration
Blood samples will be collected at following time points: pre-dose, 6, 24, 48, 72, 96 and 120 hours post dose in each of the 4 dosing weeks and additionally at 216, 336, 504, 672, 1344 and 2016 hours post last dose.
Number of participants with adverse events as a measure of safety and tolerability following single dose administration
Up to 113 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm AACTIVE_COMPARATORParticipants in this arm will receive single 200 milligram (mg) dose of GSK933776 administered by IV infusion
Arm BEXPERIMENTALParticipants in this arm will receive single 200 mg dose of GSK933776 administered SQ
Arm CEXPERIMENTALParticipants in this arm will receive 50 mg dose of GSK933776 administered SQ once weekly for 4 weeks (total dose = 200 mg).
Arm DEXPERIMENTALParticipants in this arm will receive single 200 mg dose of GSK933776 administered IM

Interventions

NameTypeDescription
GSK933776 for SQ administrationDRUGAntibody solution for subcutaneous injection with unit dose strength of 50mg/mL administered as 200 mg single dose or as repeat dose of 50 mg weekly for 4 weeks
GSK933776 for IM administrationDRUGAntibody solution for intramuscular injection with unit dose strength of 50mg/mL administered as 200 mg single dose
GSK933776 for IV administrationDRUGAntibody solution for intravenous injection with unit dose strength of 50mg/mL administered as 200 mg single dose through an IV catheter over approximately 1 hour
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female subject 18 to 50 years of age at the time of signing the informed consent * In general good health as determined by a physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject wit...

Countries:United States
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Frequently asked questions about GSK933776 for SQ administration

What is GSK933776 used for?

GSK933776 is an investigational small molecule being studied for geographic atrophy, an advanced form of age-related macular degeneration that causes progressive vision loss. It is administered subcutaneously and is being developed by GSK plc as a potential treatment for this ophthalmologic condition.

Who is developing GSK933776?

GSK933776 is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The drug is an investigational small molecule in the ophthalmology therapeutic area, currently in clinical development for geographic atrophy.

What phase is GSK933776 in?

GSK933776 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and pharmacokinetics in clinical trials.

What clinical trials is GSK933776 in?

GSK933776 has one completed Phase 1 clinical trial, identified as NCT02033668. This was a pharmacokinetic study conducted in healthy volunteers in the United States, with 36 participants enrolled. The study was randomized and actively controlled, and it evaluated the drug's pharmacokinetic profile.

Is GSK933776 the same as another drug?

GSK933776 is the name used in clinical development for this investigational small molecule. No alternative names have been reported for this drug in the available clinical trial information.