Zealand Pharma reported no dose-limiting safety findings in ZP9830’s Phase 1 multiple ascending dose (MAD) study, an early safety result as the company advances the investigational Kv1.3 blocker into disease-focused trials.
The MAD portion enrolled 32 healthy men and women. The treatment period lasted four weeks, with safety monitoring continuing through day 41. Zealand said no other significant safety concerns were identified, and adverse events among participants who received ZP9830 were mild and non-serious.
Reviews of vital signs, 12-lead ECGs, physical exams and safety laboratory tests found no clinically relevant changes, the company said. Zealand described the trial as a first-in-human, single-center study with randomization, blinding and a placebo control. The MAD portion is complete, while the broader Phase 1 trial continues to evaluate safety, tolerability and pharmacokinetics for an additional single dose.
Zealand said the drug’s pharmacokinetic parameters support longer-duration trials, but it did not disclose numerical results. Pharmacokinetics describes how a drug moves through and is processed by the body. The company’s February single-dose update reported dose-related changes in exploratory biomarkers that it said were consistent with ZP9830 engaging its target, alongside dose-proportional pharmacokinetics.
ZP9830 is designed to block Kv1.3, a potassium channel Zealand says is elevated on effector memory T cells associated with autoimmunity and chronic inflammation. The company cites preclinical work as the basis for this approach. Because the MAD portion involved healthy volunteers and focused on safety, tolerability and pharmacokinetics, its findings do not establish whether ZP9830 benefits people with autoimmune disease.
Zealand said a Phase 1b trial with efficacy endpoints is underway in people with plaque psoriasis. It plans to start a Phase 2 study in another autoimmune disease in the first half of 2027, but has not named the condition.
