The CTA is Submitted
PharmNovo is pleased to announce that a Clinical Trial Application (CTA) has been submitted to the Swedish Medical Products Agency (MPA) as well as to the ethics committee for a phase I First in Human (FIH) clinical trial with our lead candidate PN6047.
The FIH trial will be conducted at the Swedish CRO Clinical Trial Consultants AB (CTC) at their FIH facility in Uppsala. It is planned to enrol approximately 100 healthy subjects into the trial.
The CTA submission is the culmination of several years of dedicated CMC- and preclinical work creating documentation that the compound is safe for human testing, and the submission of the CTA for the FIH clinical trial represent a major milestone in the development of PN6047.
The CTA is Submitted
PharmNovo is pleased to announce that a Clinical Trial Application (CTA) has been submitted to the Swedish Medical Products Agency (MPA) as well as to the ethics committee for a phase I First in Human (FIH) clinical trial with our lead candidate PN6047.
The FIH trial will be conducted at the Swedish CRO Clinical Trial Consultants AB (CTC) at their FIH facility in Uppsala. It is planned to enrol approximately 100 healthy subjects into the trial.
The CTA submission is the culmination of several years of dedicated CMC- and preclinical work creating documentation that the compound is safe for human testing, and the submission of the CTA for the FIH clinical trial represent a major milestone in the development of PN6047.
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