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Modified Release rhTSH

Phase 1

Healthy | Small molecule | Other |Sanofi|Last Updated: Mar 18, 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

Modified Release rhTSH · 1 trial · 1 indication

Phase 1 1
NCT00137891Study Comparing Thyrogen Versus a Modified Release of Recombinant Human Thyroid Stimulating HormoneHealthy
COMPLETED46 Analytics
PHASE1COMPLETED
Study Comparing Thyrogen Versus a Modified Release of Recombinant Human Thyroid Stimulating Hormone
Healthy
NCT0013789146
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Study Endpoints

Primary Endpoints

To assess and compare the pharmacokinetics (PK) of a single intramuscular (IM) administration of 0.1 mg of Thyrogen versus a single IM administration of 0.1 mg modified release formulation of rhTSH in healthy subjects
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Study Design & Arms

MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Modified Release rhTSHDRUG -
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Eligibility Criteria

Age Range18 Years to 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Committed to follow the protocol requirements as evidenced by providing written informed consent prior to any study-related procedures being performed * Males or females, in good general health, between the ages of 18 and 40, inclusive. Females of childbearing potential must b...

Countries:United States
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Frequently asked questions about Modified Release rhTSH

What is Modified Release rhTSH used for?

Modified Release rhTSH is an investigational small molecule being studied in healthy volunteers. It is a modified release formulation of recombinant human thyroid stimulating hormone. The drug is currently in Phase 1 clinical development and is not approved for any indication.

Who makes Modified Release rhTSH?

Modified Release rhTSH is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker SNY. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy subjects.

What phase is Modified Release rhTSH in?

Modified Release rhTSH is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug is not currently in active clinical trials.

What clinical trials is Modified Release rhTSH in?

Modified Release rhTSH has one completed clinical trial, NCT00137891, titled 'Study Comparing Thyrogen Versus a Modified Release of Recombinant Human Thyroid Stimulating Hormone.' This Phase 1 study enrolled 46 healthy volunteers in the United States and was an uncontrolled, non-randomized trial.

Is Modified Release rhTSH the same as Thyrogen?

Modified Release rhTSH is not the same as Thyrogen. The clinical trial NCT00137891 directly compares Modified Release rhTSH against Thyrogen, which is a recombinant human thyroid stimulating hormone. Modified Release rhTSH is a distinct modified release formulation being investigated separately.