Phase 1 Study Assessing the Pharmacokinetics of NEX-22A in Subjects With T2D

Korábbi kezelés

• Previous participation in this trial. Participation is defined as being dosed.
• Any serious systemic infectious disease during four weeks prior to first dosing of the trial drug, as judged by the investigator.
• A positive result in the alcohol and/or urine drug screen at the screening visit.
• Inability or unwillingness to refrain from smoking and use of nicotine substitute products one day before and during the inpatient period.
• Any medication (prescription and non-prescription drugs) within 14 days before IMP administration and/or anticoagulant therapy.
• The investigator considers a subject as unsuitable for inclusion in the trial for any other reason.
  • Explanatory note on Exclusion Criterion 25: Exceptions are stable doses of metformin, SGLT2-blockers, low dose aspirin, antihypertensives, statins, thyroid hormones or occasional use of paracetamol or ibuprofen, and ,if female, with the exception of menopausal hormone replacement therapy.
  • Explanatory note on Exclusion Criterion 29: A woman is considered of childbearing potential following menarche and until becoming postmenopausal unless permanently sterile due to hysterectomy, or bilateral salpingectomy, or bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.

Más betegség

• Known or suspected hypersensitivity to the IMP or any of the excipients or to any component of the IMP formulation.
• History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
• Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the investigator.
• Signs of acute illness as judged by the investigator.
• Subjects with dermatological conditions, tattoos or large scars on the abdomen that would limit the evaluation of local tolerability, as judged by the investigator.
• Systolic blood pressure \< 90 mmHg or \>160 mmHg and/or diastolic blood pressure \< 50 mmHg or \> 95 mmHg at screening (one repeat test will be acceptable in case of suspected white-coat hypertension).
• Heart rate at rest (as measured in vital sign assessment at screening) outside the range of 50-90 beats per minute.
• Significant history of alcoholism or drug abuse as judged by the investigator or consuming more than 24.0 grams alcohol/day (for males), 12.0 grams alcohol/day (for females) on average.
• Tested positive for hepatitis Bs antigen.
• Tested positive for hepatitis C antibodies. (Presence of hepatitis C antibodies will not lead to exclusion if liver function tests are normal and a hepatitis C polymerase chain reaction is negative).
• Positive result to the test for HIV-1/2 antibodies or HIV-1 antigen.

Egyéb

• Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before enrolment in this trial.
• Clinically relevant comorbidity, capable of constituting a risk for the subject when participating in the trial or of interfering with the interpretation of data.
• Clinically significant abnormal values for haematology, biochemistry, coagulation, or urinalysis at screening as judged by the investigator.
• Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening, as judged by the investigator.
• Proliferative retinopathy or maculopathy as judged by the investigator based on a recent (\<1.5 years) ophthalmologic examination.
• Severe neuropathy, in particular autonomic neuropathy, as judged by the investigator.
• Former or current use of liraglutide or any other GLP-1 receptor agonists (exenatide, semaglutide) except for the use in clinical trials.
• Current use of any insulin or sulfonylureas.
• Smoking more than 5 cigarettes or the equivalent per day.
• Blood donation or blood loss of more than 500 mL within the last 3 months.
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
• Committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
• Women of childbearing potential.
• Trial site personnel directly affiliated with this trial and their immediate families (spouse, biological or legal guardian, child, or sibling).

• Signed and dated informed consent obtained before any trial-related activities. Trial-related activities are any procedures that would not have been done during normal management of the subject.
• Male or female subject with type 2 diabetes mellitus.
• Metformin therapy without change in dose for the last 3 months.
• Age between 18 and 65 years, both inclusive.
• Body Mass Index (BMI) between 18.5 and 35.0 kg/m\^2, both inclusive.
• HbA1c \> 6.5% and \<= 9.0%.
• Diabetes duration of at least 1 year.