LIB-01 is intended for the treatment of erectile dysfunction and premature ejaculation. Credit: BlurryMe/Shutterstock.com.

Dicot has dosed the first participants in a Phase I clinical trial of LIB-01 to treat erectile dysfunction and premature ejaculation.

The double blinded, placebo-controlled study is performed in a clinic owned by Dicot’s partner CTC at the University Hospital in Uppsala.

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It includes both single dosing and repeated dosing studies, and the primary aim is to assess the safety of LIB-01.

Approximately 50 healthy subjects will be divided into different dose groups in the single-dose part of the study. They will receive either LIB-01 or a placebo.

Participants will be reviewed for three days and blood samples will be collected. Their blood pressure and ECG will also be monitored for safety assessments.

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After the completion of the single dose section, participants will receive repeated doses of LIB-01 in the second part of the study.

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Dicot CEO Elin Trampe said: “The start of the study has gone completely according to plan, and it feels fantastic that the first dose of LIB-01 has now been administrated.

“We are so grateful to all study participants who contribute to significant research through this. It brings us closer to a new improved treatment for all men and couples who suffer from erectile problems.”

The company is planning to initiate a Phase IIa study of LIB-01 next year.

It also investigated the toxic effects of LIB-01 by studying the pharmacology and kinetics of the drug substance, as well as performing a comprehensive safety evaluation in its preclinical development programme.