SAB Biotherapeutics Inc (NASDAQ:SABS) announced that the first HUMAN trial participants (Fully HUman anti-thymocyte biologic in a first-in-MAN clinical study) have been dosed in Australia. 

This Phase 1 randomized, double-blind, placebo-controlled, single-ascending dose, adaptive design clinical study was designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous SAB-142 in healthy volunteers and participants with type-1 diabetes (T1D).

SAB-142 is a first-in-class, fully human anti-thymocyte immunoglobulin developed as a disease-modifying treatment to delay the onset and progression of T1D.

SAB-142 directly and specifically targets multiple immune cells involved in destroying insulin-producing pancreatic beta cells to potentially preserve beta cell function.

The trial's primary objective is two-fold:

• To generate data on differentiated safety and immunogenicity 
• To establish a Proof of Biological Activity (POBA) for SAB-142. 

SAB is on track to file an Investigational New Drug (IND) application for SAB-142 with the FDA in 2024, along with filings in the U.K. and EU countries to enable efficient progress towards the Phase 2b development. 

Price Action: SABS shares closed at $0.92 on Tuesday.