First participants dosed in Dicot's phase 1 trial
Press release: Uppsala, September 4, 2023. The potency drug developer Dicot announces today that the first study participants have been dosed in the company's clinical phase 1 trial.
Dicot has recently started the first clinical trial with its potency drug candidate LIB-01. The primary objective of the study is to evaluate the safety of LIB-01 and consists of two parts: single dosing and repeated dosing. The recruitment of healthy participants for the first part of the study, the single dosing, started immediately after approval from the authorities and today the first participants have been dosed. The trial is performed at the University Hospital in Uppsala, where the company's partner CTC has its clinic.
The single-dose part of the study involves around 50 participants, divided into different dose groups and where the doses are gradually increased in subsequent groups. After dosing, participants are admitted for a period of three days during which frequent safety assessments are conducted, including blood sample collection, blood pressure monitoring, and ECG, all of which are standard procedures in this type of first-in-human study.
The single dosing will be followed by the second part of the study where repeated doses are given to each of the participants. The entire phase 1 trial is double blinded and placebo-controlled, which means that some participants receive LIB-01 and some receive placebo and that neither the participant nor the investigator know who receives LIB-01 and who receives placebo.
"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", states Dicot´s CEO, Elin Trampe.
For further information, please contact:
Elin Trampe, CEO
Phone: +46 72 502 10 10
E-mail: [email protected]
About Dicot AB
Dicot is developing the drug candidate LIB-01, which will be a potency agent to better treat erectile dysfunction and premature ejaculation. The ambition is to create a drug with significantly longer effect and far fewer side effects, compared to current available drugs. Today, over 500 million men suffer from these sexual dysfunctions and the market is valued at USD 8 billion. Dicot's strategy is to develop LIB-01 under own auspices until phase 2a studies and thereafter in partnership with larger, established pharmaceutical companies, finance and develop LIB-01 further to a registered pharmaceutical on the world market.
Dicot is listed on Spotlight Stock Market and has approximately 4,400 shareholders. For more information, please visit www.dicot.se.
Dicot utvecklar ett modernt potensläkemedel som ska behandla erektionssvikt och för tidig utlösning bättre än befintliga preparat.