Our lead product, KBPA101, is a fully human monoclonal antibody targeting Pseudomonas aeruginosa bacteria. Based on the data from our completed Phase I clinical trial, it can be concluded that KBPA101 is safe and well tolerated in humans.
Phase I Study
A randomised, double-blind and placebo-controlled Phase I clinical study has been performed with KBPA101 in healthy subjects. The primary objective of the study was to evaluate the safety of KBPA101. The evaluation of the pharmacokinetics and pharmacodynamic effects of KBPA101 were secondary objectives. Thirty-two volunteers were sequentially enrolled into one of four dosage groups. For each cohort (comprising 8 subjects), six subjects were randomised to receive KBPA101 and two received placebo.
All adverse events were of mild or moderate intensity, and all adverse events resolved without sequelae. There was no increase in the incidence of adverse events with increasing dose. There were no serious or severe adverse events, and none of the subjects had to discontinue the study due to an adverse event. Also, no clinically relevant findings were observed in vital signs, ECGs, or physical examinations.
The mean half-lives at each dose level were comparable to the half-life of a native IgM.
Results from this clinical study demonstrate that our fully human monoclonal antibody, KBPA101, is well tolerated and safe. KBPA101 will now be advanced into Phase II trials for proof-of-concept in a patient population.
