A 4-week, first in human study assessing the safety and tolerability of different doses of oral insulin (EA-Ins-IQ-100) in healthy volunteers

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.

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12626000827336

Enrollment

Registered

2026-07-09

Start date

2026-09-04

Completion date

2026-10-15

Last updated

2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A healthy volunteer study testing a new oral insulin, EA-Ins-IQ-100.. This study will assess the safety, tolerability, and pharmacokinetics of different doses of EA-Ins-IQ-100 after single oral administrations.

Interventions

12 participants will be randomly assigned to a unique placebo-controlled ascending dosing schedule in this study. Dosing will consist of 4 dosing days spaced apart by at least 1 week. The four dosing days will involve 4 doses of EA-Ins-IQ-100 in ascending strengths as follows: Dosing day 1: 2.25mg (equiv. to 62.5IU in 1 capsule), Dosing Day 2: 4.5mg (equiv. to 125IU in 2 capsules), Dosing Day 3: 6.75mg (equiv, to 187.5 IU in 3 capsules) Dosing Day 4: 9mg (equiv. to 250IU in 4 capsules). Participants will either receive placebo or EA-Ins-IQ-100 at each dosing day. 2 Sentinel participants will receive 2 doses of active and 2 placebo doses in the four dosing days. The rest of the cohort will be assigned 3 active doses and 1 placebo dose for their four dosing days.

Study design

Allocation

Randomised controlled trial

Intervention model

Other

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

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 -1. 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.

Outcome results