A Phase Ia, randomised, double blind, placebo-controlled study to assess the safety and tolerability of single ascending doses of the oral insulin formulation EA- Ins-IQ-100 in healthy volunteers.

Endo Axiom Pty Ltd0 个研究点目标入组 12 人开始时间: 2026年9月4日最近更新: 2026年8月24日

适应症

试验速览

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•Healthy volunteers with no significant underlying conditions, as evidenced by ECG, blood sampling and medical history review.
•willing and able to understand and sign a consent form.
•Body weight between 50-100Kg and BMI between 18 and 32 kg/m2

•History or presence of clinically significant gastrointestinal pathology or symptoms, liver or kidney disease or any condition that might interfere with the absorption, distribution, metabolism or excretion of the drug in the opinion of the principal investigator or delegate.
•Positive pregnancy test or currently breastfeeding
•eGFR < 60mL/min/1.73m2
•Evidence of impaired hepatic function, as evidenced by ALT or AST greater than or equal to 1,5 x ULN; OR total bilirubin >1.5 x ULN
•Current or chronic history of liver disease.
•History of severe allergic reaction, or anaphylaxis to drugs or food.
•Has an active, acute or chronic infection
•Positive urine drug screen and/ or alcohol breath test during screening or on day -
•Clinically significant changes on ECG
•Has a QTcF interval greater than 450 msec for males, greater than 470 for females, has a complete left bundle branch block, or has a history or current evidence of additional risk factors for torsades de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome) at screening
•Any other conditions for which, in the opinion of the principal investigator or delegate, participation would not be in the best interested of the participant, or that could prevent, limit, or confound the protocol-specified assessment.

发起方

Endo Axiom Pty Ltd