Phase I study completed for PN6047
In August 2022, PharmNovo initiated the First-In-Human, (FIH), clinical study for the company’s drug candidate PN6047, aimed at evaluating its safety and tolerability. By August 2023, the study was completed, involving 104 subjects across 13 cohorts, which included both Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) cohorts. Each cohort consisted of 8 subjects, with 6 receiving active treatment and 2 receiving placebo.
The headline results of the Phase I study show that PN6047 is well tolerated when taken with food at all tested doses. The pharmacokinetics were found to be robust and predictable, making it suitable for three-times-daily administration. This dosing regimen is expected to provide an effective drug exposure level.
PN6047 exhibited no signs of adverse events typically associated with conventional opioids, such as respiratory depression, seizures, abuse potentials such as euphoria or withdrawal symptoms, cardio-vascular concern, pruritus or constipation.
The completed Phase I study with PN6047, demonstrating both safety and tolerability at doses expected to be efficacious. Furthermore, the study indicates that PN6047 offers a different safety profile compared to conventional opioids in terms of side effects and pharmacology. A major milestone has been achieved!
Phase I study completed for PN6047
In August 2022, PharmNovo initiated the First-In-Human, (FIH), clinical study for the company’s drug candidate PN6047, aimed at evaluating its safety and tolerability. By August 2023, the study was completed, involving 104 subjects across 13 cohorts, which included both Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) cohorts. Each cohort consisted of 8 subjects, with 6 receiving active treatment and 2 receiving placebo.
The headline results of the Phase I study show that PN6047 is well tolerated when taken with food at all tested doses. The pharmacokinetics were found to be robust and predictable, making it suitable for three-times-daily administration. This dosing regimen is expected to provide an effective drug exposure level.
PN6047 exhibited no signs of adverse events typically associated with conventional opioids, such as respiratory depression, seizures, abuse potentials such as euphoria or withdrawal symptoms, cardio-vascular concern, pruritus or constipation.
The completed Phase I study with PN6047, demonstrating both safety and tolerability at doses expected to be efficacious. Furthermore, the study indicates that PN6047 offers a different safety profile compared to conventional opioids in terms of side effects and pharmacology. A major milestone has been achieved!
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