Halia Therapeutics, Inc., a clinical-stage biopharmaceutical company redefining treatment paradigms through inflammation-targeted and resilience-driven therapies, today announced the successful completion of its first-in-human Phase 1 clinical trial evaluating HT-4253 in healthy adult volunteers.
The randomized, double-blind, placebo-controlled single- and multiple-ascending-dose (SAD/MAD) trial (ClinicalTrials.gov Identifier: NCT06537817) was conducted at CMAX Clinical Research in Adelaide, Australia. A total of 80 participants were dosed across 10 cohorts. The primary objectives of the trial were safety and tolerability, with secondary endpoints assessing pharmacokinetics (PK) and pharmacodynamics (PD. HT-4253 was generally well tolerated across all dose levels, with no serious adverse events reported. A comprehensive Clinical Study Report (CSR) is anticipated in Q4 2025.
“The successful completion of this first-in-human study marks a significant milestone for Halia and provides compelling validation of HT-4253’s safety, tolerability, and its potential to address a critical unmet need in neurodegenerative diseases, where dysregulated immune responses play a central role,” said Dr. David Bearss, Chief Executive Officer of Halia Therapeutics. “These results show that HT-4253 can be safely administered at pharmacologically active doses, positioning us to move forward into patient populations with confidence. Backed by robust preclinical data and a mechanism inspired by naturally resilient individuals, HT-4253 represents a potentially transformative approach to modulating neuroinflammation in diseases such as Alzheimer’s. Our team is now focused on preparing for the next phase of clinical development and identifying strategic opportunities to accelerate the program. Ultimately, our goal is to harness the protective biology observed in genetically resilient individuals and translate it into medicines that can delay or prevent disease in at-risk populations.
