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A Study of PATAS Using Single Ascending Doses in Healthy Volunteers and Multiple Ascending Doses in Diabetic Subjects

RecruitingPhase 1Ages 18 Years - 65 YearsAllAdipoPharma LLC
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In plain words

What the trial is, and whether it could suit you

This is 2-part study. The primary objective of Part 1 is to evaluate safety and tolerability of single subcutaneous (SC) doses of PATAS in healthy subjects. The secondary objective of this study is to determine the pharmacokinetics (PK) of single SC doses of PATAS in healthy subjects. The primary objectives of Part 2 are to evaluate the safety and tolerability of 4 weekly SC doses of PATAS in subjects with T2D; and to determine the PK and pharmacodynamics (PD) of 4 weekly SC doses of PATAS in subjects with T2D. Secondary objectives of Part 2 include evaluation of the potential effect of multiple SC doses of PATAS on markers of glycemic control, as measured by glucose levels, insulin levels, and other metabolomic biomarkers and characterization of of adverse event (AE) profiles of the various dose levels of PATAS.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Part 1: Single Ascending Dose Inclusion criteria 1. Healthy male and female subjects, 18 to 55 years of age, inclusive, at the time of signing the Informed Consent Form (ICF); 2. Willing and able to give written informed consent for participation in the study prior to the initiation of any Screening or study-specific procedures; 3. Body mass index (BMI) within the range of 20.0 to 35.0 kg/m2, inclusive, at Screening; 4. In generally good health, as judged by the Investigator, based upon medical/surgical history and the results of physical examination, vital signs, clinical laboratory assessments, and 12-lead electrocardiogram (ECG) at Screening and at Check-In (Day -1); 5. Female subjects must have a negative serum pregnancy test result at the Screening Visit and a negative urine pregnancy test at Check-In (Day -1) (prior to the first dose of study drug) and must not be pregnant, lactating, or planning a pregnancy from the Screening Visit to 90 days after the last dose of study drug; 6. Negative test result for severe acute respiratory syndrome coronavirus 2 at Check-In (Day -1); and 7. Willing to comply with all study procedures and requirements throughout the duration of the study. Exclusion Criteria: <!-- --> 1. Clinically significant history of asthma, eczema, or any other allergic condition or previous severe hypersensitivity; Note: Non-active hay fever is not exclusionary. 2. Liver function tests (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], alkaline phosphatase \[ALP\], total bilirubin) outside the following upper limits of normal (ULNs) at Screening or at Check-In (Day -1): a. For ALT and AST, measurements \> ULN; b. For ALP, measurements \>ULN; or c. For total bilirubin, measurements \> ULN. 3. Estimated glomerular filtration rate \</= 90 mL/min/1.73 m2 based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening or at Check-In (Day -1); 4. Thyroid-stimulating hormone (TSH) outside of reference range (e.g., TSH \<1 ร— lower limit of normal \[LLN\] or TSH \>1 ร— ULN) at Screening; Note: Abnormal TSH results will reflex to a free thyroxine (T4) test. 5. History of unexplained syncope, cardiac arrest, unexplained cardiac arrythmias or torsades de pointes, or structural heart disease; 6. Personal or family history of long QT syndrome; 7. Clinically significant history of any disease or disorder (i.e., gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric, or metabolic) deemed to be exclusionary, as judged by the Investigator; 8. Abnormal pulse rate or blood pressure (BP) measurements at Screening, defined as: a. Pulse rate \<40 bpm or \>100 bpm; b. Systolic BP \< 90 mmHg or \>140 mmHg; or c. Diastolic BP \< 50 mmHg or \> 90 mmHg. 9. Clinically significant ECG abnormalities at Screening or at Check-In (Day -1), defined as prolongation of the average QTcF interval \> 450 ms for males and \>470 ms for females, or other clinically significant ECG abnormalities per Investigator discretion; 10. Positive for hepatitis B surface antigen, HIV antibody, or hepatitis C virus antibody at Screening; 11. Receipt of any investigational product within 30 days prior to first study drug administration (90 days for investigational biologic agents) or 5 half-lives prior to first study drug administration, whichever is greater, or participation in \>3 clinical studies within 12 months; 22. Known or suspected hypersensitivity to PATAS or any components of the formulation used (sodium hydroxide or mannitol); Part 2: Multiple Ascending Dose Inclusion Criteria 1. Male and female subjects, 18 to 65 years of age, inclusive, at the time of signing the ICF; 2. Willing and able to give written informed consent for participation in the study prior to the initiation of any Screening or study-specific procedures; 3. A diagnosis of T2D \>6 months before Screening 4. Subjects should be on a stable dose of 1. an oral monotherapy (permitted monotherapies include metformin and dipeptidyl peptidase 4 inhibitors) for at least 90 days before Screening 2. or a dual therapy (including metformin and dipeptidyl peptidase 4 inhibitors) for at least 6 months before Screening 3. or managing the condition through diet and exercise for at least 90 days before Screening; 5. Glycated hemoglobin 7 % and \<10.5% at Screening; 6. BMI within the range of 25.0 to 40.0 kg/m2, inclusive, at Screening; 7. In generally good health, as judged by the Investigator, based upon medical/surgical history and the results of physical examination, vital signs, clinical laboratory assessments, and 12-lead ECG at Screening and at the pre-dose Check-In (Day -1); 8. Female subjects must have a negative serum pregnancy test result at the Screening Visit and a negative urine pregnancy test at the pre-dose Check-In (Day -1) (priorto the first dose of study drug) and must not be pregnant, lactating, or planning a pregnancy from the Screening Visit to 90 days after the last dose of study drug; 9. Female subjects of childbearing potential (i.e., ovulating, premenopausal, and not permanently surgically sterile) with male partners and all male subjects with female partners of childbearing potential will be included if they are either sexually inactive (complete abstinence from heterosexual activity if in line with the subject's preferred and usual lifestyle) and agree to continue complete abstinence for 90 days after the last administration of study drug, or, if sexually active, agree to use an effective contraceptive regimen during their participation in the study and for 90 days after the last administration of study drug. Effective contraceptive methods are defined as those with 90% or greater efficacy and include the following: * For male subjects enrolled in the study: Condoms with spermicide; or Surgical sterilization (vasectomy) of the subject at least 6 months befor
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What it tests

  • PATAS Trifluoroacetate
  • Placebo
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Where

3 sites
Arizona Clinical Trials
Chandler, United States
Clinical Pharmacology of Miami
Miami, United States
Progressive Medical Research
Port Orange, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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