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Modified Release rhTSH · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| Modified Release rhTSH | DRUG | - |
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...
Modified Release rhTSH is an investigational formulation of recombinant human thyroid stimulating hormone developed by Sanofi. It is designed to release the hormone in a modified, extended manner compared with the standard immediate-release version. It has been studied in healthy adult volunteers rather than in patients with a specific disease.
Modified Release rhTSH is being developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi is the sponsor behind the clinical program for this reformulated version of recombinant human thyroid stimulating hormone.
Modified Release rhTSH is in Phase 1 clinical development. It is an investigational product and is not approved by the FDA. The Phase 1 program has completed, with one trial conducted to date.
Modified Release rhTSH has been evaluated in one completed Phase 1 trial, NCT00137891, titled a study comparing Thyrogen versus a modified release of recombinant human thyroid stimulating hormone. That trial enrolled 46 healthy adult volunteers in the United States and was an uncontrolled study without randomization or blinding.
No. Modified Release rhTSH is a distinct modified-release formulation, while Thyrogen is the comparator used in the Phase 1 trial NCT00137891. That study directly compared Thyrogen against the modified release version of recombinant human thyroid stimulating hormone in healthy volunteers.
The Phase 1 trial NCT00137891 compared Thyrogen with a modified release formulation of recombinant human thyroid stimulating hormone. It enrolled 46 healthy volunteers aged 18 years and older of all sexes in the United States. The study was uncontrolled, non-randomized, and has been completed.