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Formulation buffers

Phase 1

Healthy | Unknown | Other |Sanofi|Last Updated: Jan 31, 2013

Success Probability

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Market & Valuation

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Trial Design

Double-BlindUNCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Formulation buffers · 1 trial · 1 indication

Phase 1 1
NCT01401764Study Comparing The Tolerability Of Three Excipient Formulations Administered Subcutaneously To Healthy SubjectsHealthy
COMPLETED30 Analytics
PHASE1COMPLETED
Study Comparing The Tolerability Of Three Excipient Formulations Administered Subcutaneously To Healthy Subjects
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Relative perception of pain of platform II versus PASS using a likert scale
0 minute after injections
Relative perception of pain of PASS versus Arg 100 using a likert scale
0 minute after injections
Perception of pain of Platform II, PASS and Arg 100 using VAS scale.
0 minute after injections
Perception of burning of Platform II, PASS and Arg 100 using VAS scale.
0 minute after injections
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Study Design & Arms

AllocationNA
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Platform II, PASS, ARG 100OTHER -

Interventions

NameTypeDescription
Formulation buffersOTHERPlatform II: Histidine, Polysorbate-80 PASS: Phosphate, Arginine, NaCl ARG 100: Phosphate, 100 mM Arginine
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or female subjects(no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory. * Body mass index of 17.5 to 30.5 kg/m2; and a to...

Countries:Belgium
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Frequently asked questions about Formulation buffers

What is Formulation buffers used for?

Formulation buffers is an investigational drug being studied in healthy subjects. It is being evaluated for tolerability when administered subcutaneously. The drug is currently in Phase 1 clinical development.

Who makes Formulation buffers?

Formulation buffers is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker SNY.

What phase is Formulation buffers in?

Formulation buffers is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study has been completed.

What clinical trials is Formulation buffers in?

Formulation buffers has one completed Phase 1 clinical trial, identified as NCT01401764. This study compared the tolerability of three excipient formulations administered subcutaneously to healthy subjects in Belgium.

Is Formulation buffers being studied in healthy volunteers?

Yes, Formulation buffers is being studied in healthy volunteers. The completed Phase 1 trial enrolled 30 healthy subjects, with an age range starting at 18 years, and included both males and females.