Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as NUV001 active cohort 1
NUV001 active · 1 trial · 1 indication
Percentage of Participants Who Experienced Any Adverse Events.
Subject incidence of treatment-emergent clinically significant changes in vital signs (Systolic and Diastolic Blood Pressure in millimeters of mercury (mmHg), Heart Rate in beats per minute (bpm), and Oral Body temperature in Celsius).
Subject incidence of treatment-emergent clinically significant changes in 12-lead ECGs (PR interval in milliseconds (msec), QRS duration in milliseconds (msec), QRS axis in milliseconds (msec), QT interval in milliseconds (msec)).
Subject incidence of treatment-emergent clinically significant changes in clinical laboratory safety tests (Complete Blood Count (absolute counts and %), Fasting blood glucose concentration and Serum concentrations in Electrolytes, Protein, Albumin, Total Bilirubin, Blood urea nitrogen, Creatinine, Aspartate Aminotransferase, Alanine Aminotransferase, estimated Glomerular Filtration Rate (eGFR using CKD EPI equation, Activated partial thromboplastin time (aPTT) and Prothrombin Time test (PT) with International Normalized Ratio (INR)).
Subject incidence of treatment-emergent clinically significant changes in Urinalysis safety tests (pH, glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, and leukocyte esterase).
Subject incidence of treatment-emergent clinically significant changes in Weight in kilograms (Kg).
| Arm | Type | Description |
|---|---|---|
| NUV001 active | EXPERIMENTAL | Single oral administration (treatment period 1 - SAD) and after a washout of at least 5 days, repeated once daily (q.d.) administrations for 14 days (treatment period 2 - MAD) |
| NUV001 Placebo | PLACEBO_COMPARATOR | Single oral administration (treatment period 1 - SAD) and after a washout of at least 5 days, repeated once daily (q.d.) administrations for 14 days (treatment period 2 - MAD) |
| Name | Type | Description |
|---|---|---|
| NUV001 active cohort 1 | DRUG | 6 participants will be assigned to receive active treatment |
| NUV001 active cohort 2 | DRUG | 6 participants will be assigned to receive active treatment |
| NUV001 active cohort 3 | DRUG | 6 participants will be assigned to receive active treatment |
| NUV001 active cohort 4 | DRUG | 6 participants will be assigned to receive active treatment |
| NUV001 placebo cohort 1 | DRUG | 2 participants will be assigned to receive placebo |
| NUV001 placebo cohort 2 | DRUG | 2 participants will be assigned to receive placebo |
| NUV001 placebo cohort 3 | DRUG | 2 participants will be assigned to receive placebo |
| NUV001 placebo cohort 4 | DRUG | 2 participants will be assigned to receive placebo |
Inclusion Criteria: Participants must satisfy all the following inclusion criteria before being allowed to enter the study: 1. Male or female 18 to 55 years of age inclusive, at screening. 2. A body mass index (BMI) between 18.00 and 30.00 kg/m² inclusive and a body weight between 60 kg and 100 kg...