Lipum AB (publ) announced that the clinical phase 1 study with the drug candidate SOL-116 is proceeding as planned. After a fourth dose escalation, a safety evaluation has now been conducted and as expected, data show that SOL-116 remains safe and well tolerated. The study is therefore continuing as planned with a higher dose level for the fifth group.

SOL-116 is being developed for the treatment of chronic inflammatory diseases. The study is designed as a double-blind, randomized and placebo controlled FIH (First In Human) study and includes up to six dose groups of healthy subjects. In addition, a group of patients diagnosed with rheumatoid arthritis will participate in the study.

The primary objective of the study is to establish safety and tolerability of SOL-116, and the secondary objective is to study its pharmacokinetics. The study is a dose escalation study, and each subject receives only one dose of SOL-116 (Single Ascending Dose, SAD). After safety evaluation of a whole group, the dose is gradually increased for each new group included in the study.