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A multiple ascending dose trial investigating safety, tolerability, and pharmacokinetics of NNC0361-0041 administered subcutaneously to patients with type 1 diabetes mellitus

Recruiting

This study is looking at 48 adult patients that have been diagnosed with type 1 diabetes within the past 4 years and giving them subcutaneous injections weekly of NNC0361-0041 plasmid to assess the safety and tolerability. This is a phase1 study that will enrolled over a 28 week period.

I'm interested

All
18 Years to 45 Years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Willing to provide Informed Consent
• Participants must live in a location with rapid access to emergency medical services
• Age 18-45 years (both inclusive) at the time of signing informed consent
• Must have a diagnosis of T1D for less than 48 months at randomization
• Must have at least one diabetes-related autoantibody present (GAD65A; mIAA, if obtained within 10 days of the onset of insulin therapy; IA-2A; ICA; or ZnT8A)
• Must have stimulated C-peptide levels greater than or equal to 0.2 pmol/ml measured during an MMTT conducted at least 21 days from diagnosis of diabetes and within one month (37 days) of randomization
• Be willing to comply with intensive diabetes management
• HbA1c ≤8.5% at screening
• Subjects who are CMV and/or EBV seronegative at screening must be CMV and/or EBV PCR negative within 37 days of randomization and may not have had signs or symptoms of a CMV and/or EBV compatible illness lasting longer than 7 days within 37 days of randomization
• Be up to date on recommended immunizations
• Be at least 6 weeks from last live immunization
• Be at least 4 weeks from killed vaccine other than flu vaccine
• Participants are required to receive killed influenza vaccination at least 2 weeks prior to randomization when vaccine for the current or upcoming flu season is available
• Be willing and medically acceptable to postpone live vaccines during the treatment period and for 3 months following last dose of study drug
• If participant is female with reproductive potential, she must have a negative pregnancy test at screening and be willing to avoid pregnancy using a highly effective contraceptive method for the 12 months of the study
• Males of reproductive age must use adequate contraceptive method during the treatment phase and for 3 months following last dose of study drug
• Participants are required to receive an authorized non-live COVID-19 vaccination and be fully vaccinated, including eligible boosters as indicated, at least two weeks prior to randomization.
Exclusion Criteria:
Potential participants must not meet any of the following exclusion criteria:
• One or more screening laboratory values as stated
• Leukocytes < 3,000/μL
• Neutrophils <1,500 /μL
• Lymphocytes <800 /μL
• Platelets <100,000 /μL
• Haemoglobin <6.2 mmol/L (10.0 g/dL)
• Potassium >5.5 mmol/L or <3.0 mmol/L
• Sodium >150mmol/L or < 130mmol/L
• AST or ALT ≥2.5 times the upper limits of normal
• Bilirubin ≥ 1.5 times upper limit of normal
• Glomerular Filtration Rate (eGFR) value of eGFR < 60 ml/min/1.73 m2 as defined by KDIGO 2012 (43)
• Any other laboratory abnormality that might, in the judgment of the investigator, place the subject at unacceptable risk for participation in this trial
• Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control within prior 7 days of screening
• Use of other immunosuppressive agents including chronic use of systemic steroids. Topical products are acceptable (nasal, conjunctival, skin)
• Have active signs or symptoms of acute infection at the time of randomization
• Have current, confirmed COVID-19 infection
• Chronic active infection other than localized skin infections
• Have evidence of prior or current tuberculosis infection as assessed by PPD, interferon gamma release assay or by history
• Have evidence of current or past HIV, Hepatitis B infection
• Have evidence of active Hepatitis C infection
• Vaccination with a live virus within the last 6 weeks and killed vaccine within 4 weeks (except 2 weeks for flu vaccine)
• Be currently pregnant or lactating, or anticipate getting pregnant within the one-year study period.
• Have severe obesity: adults BMI ≥ 40
• Have a history of malignancies
• Untreated hypothyroidism or active Graves' disease
• History of severe reaction to prior vaccination
• Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days after last blood draw (or 5 half-lives of investigational drug, whichever is greater) before screening, or currently enrolled in any other clinical trial
• Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the trial
• Supine blood pressure at screening outside the range of 90-139 mmHg for systolic or 50-89 mmHg for diastolic. To exclude white-coat nervousness a single repeat measurement is allowed
• Have any complicating medical issues or abnormal clinical laboratory results that may interfere with study conduct, or cause increased risk
• Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results

Drug: NNC0361-0041, Other: Placebo

Type I Diabetes

Antoinette Moran - moran001@umn.edu
Antoinette Moran
Phase 1
STUDY00011044
NCT04279613
See this study on ClinicalTrials.gov

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