Chronic Leukemia Inflammatory Diseases
Conditions
Interventions
Group A and B:
The table below shows the planned dose levels for each group. The doses after
treatment period 1 can be adjusted. For example because the study compound had
more or less effect than w
Sponsors
Carna Biosciences, Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Must have signed an ICF prior to screening, indicating that he/she understands the purpose of, and procedures required for, the trial and are willing to participate in the trial. 2. Healthy males or females of non-childbearing potential, between 18 and 64 years of age, inclusive, at screening. 3. Body Mass Index (BMI; weight in kg divided by length in square meters) between 18.0 and 30.0 kg/m2, inclusive, at screening. 4. Good physical and mental health as established by medical history, physical examination, electrocardiogram (ECG) and vital signs (including temporal body temperature) recording, and results of biochemistry, hematology, and urinalysis tests during screening as judged by the investigator. 5. Non-smoker/non-user of nicotine-containing products for at least 3 months prior to screening, as confirmed by a urine cotinine test at screening and on Day -1 of the first treatment period of each cohort.
Exclusion criteria
Exclusion criteria: 1. History of or current clinically significant medical illness including (but not limited to) gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, endocrinologic, genitourinary, renal, hepatic, respiratory, inflammatory, neoplastic, or infectious disease, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the trial results. 2. Clinically relevant abnormal laboratory, ECG recordings, vital signs or physical findings at screening or on Day -1 of the first treatment period, as judged by the investigator. 3. Values of hepatic aminotransferase (ALT and/or AST) > 1.5 × the upper limit of normal range (ULN) at screening or on Day -1 of the first treatment period. 4. Values of GGT and/or ALP > 1.25 x ULN at screening or on Day -1 of the first treatment period. 5. Values of total bilirubin > ULN at screening or on Day -1 of the first treatment period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • To investigate the safety and tolerability of AS-1763 following single-dose oral administration in healthy subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| • To investigate the pharmacokinetics (PK) of AS-1763 (in plasma) following single-dose oral administration in healthy subjects. • To investigate the pharmacodynamics (PD) of AS-1763 (in blood) following single-dose oral administration in healthy subjects. • To investigate potential QT effects of AS-1763 following single-dose oral administration in healthy subjects, using serial electrocardiograms (ECGs) extracted from continuous recordings (Holter) combined with AS-1763 plasma concentration: QT interval corrected for heart rate (QTc) analysis. | — |
Countries
Netherlands
Outcome results
None listed