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