Investigating the safety, tolerability and immune modulation of a novel treatment for stage 3 type one diabetes and help preserve remaining beta cells.

Phase 1

• Conditions: Diabetes; Type one diabetes; Metabolic and Endocrine; Stage 3 type one diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12624001043527
• Lead Sponsor: niQuest Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-28
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1.Adults who meet the American Diabetes Association T1D criteria; Female of child-bearing potential must agree to use two effective forms of contraception from enrolment to completion of the study
2.Diagnosis of T1D within 5 years of enrolment;
3.Positive for at least one diabetes-related autoantibody, including but not limited to: Glutamate decarboxylase-65 (GAD-65); Insulin, if obtained within 10 days of the onset of exogenous insulin therapy; Insulinoma antigen-2 (IA-2); or Zinc transporter-8 (ZnT8);
4.Random C-peptide >0.2 nmol/L or MMTT-stimulated mean C-peptide AUC of >0.2 nmol/L;
5.Positive for HLA-DQB1*03:02 or HLA-DQB1*02:01;
6.Written informed consent;
7.Agree to forego vaccinations during the first 4 weeks of the study.

Exclusion Criteria

1.Latent autoimmune diabetes of adults (LADA)
2.History of malignancy or serious uncontrolled cardiovascular, nervous system, pulmonary, renal, liver or gastrointestinal disease.
3.An active inflammatory disease other than T1D with the exception of stable thyroid or celiac disease;
4.Current or prior treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status e.g. including Teplizumab, TNF inhibitors or JAK inhibitors.
5.Current use of drugs other than insulin to treat hyperglycaemia (e.g. metformin, sulfonylureas, glinides, thiazolidinedione, GLP1 agonists, SGLT2 inhibitors, DPP-IV inhibitors, or amylin).
6.Current use of any medication known to significantly influence glucose tolerance (e.g., atypical antipsychotics, diphenylhydantoin, niacin, systemic glucocorticoids, beta blockers).
7.Serious infection requiring hospitalisation within last 28 days;
8.Receipt of any live attenuated vaccines within 4 weeks prior to entry;
9.Major surgery within last 28 days;
10.CBC, haemoglobin, platelets, creatinine, bilirubin, and AST/ALT greater than 1.5 x out of normal laboratory ranges at entry
11.Positive serology for HIV, or infection with HBV or HCV;
12.Any known or suspected allergies to the study drug or its constituents or a history of severe allergy or anaphylaxis;
13.Inadequate venous access to allow collection of blood samples;
14.History of drug or alcohol abuse;
15.Participation in any other clinical trial of an investigational medical product or device within 30 days or 5 half-lives before study start, whichever comes later;
16.If, in the opinion of the PI, the participant appears not to be able to perform the needed responsibilities of participation in the clinical study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified