hives and rheumatoid arthritis
Conditions
Interventions
The volunteer will be given AS-0871 (Part 2: or placebo) as oral capsules (part
1) or tablets (part 1a and 2) with 240 milliliters (mL) of (tap) water. Intake
of the study compound should occur with
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 indicating that he/she is 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) between 18.0 and 30.0 kg/m2, inclusive, at screening. 4. Good physical and mental health as established by medical history, physical examination, ECG, and vital signs (including temporal body temperature) recording, and results of biochemistry, coagulation (Part 2 only), 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, to be confirmed by a urine cotinine test at screening and on Day -1 (of the first treatment period, as applicable). Further criteria apply, see protocol.
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, hematologic (including coagulation disorders), 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 values for hematology, coagulation (Part 2 only), biochemistry, or urinalysis at screening or on Day -1 (of the first treatment period, as applicable), as judged by the investigator. 3. Values of hepatic aminotransferase (ALT and/or AST) >1.5xULN at screening or on Day -1 (of the first treatment period, as applicable). 4. Values of GGT and/or ALP >1.25xULN at screening or on Day -1 (of the first treatment period, as applicable). 5. Values of total cholesterol and LDL cholesterol >1.25xULN at screening or on Day -1 (of the first treatment period, as applicable). Further criteria apply, see protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: To explore the effect of food on the plasma PK of AS-0871, formulated as AS-0871/DES capsules, following single-dose oral administration in healthy subjects. Part 1a: To explore the effect of food on the plasma PK of AS-0871, formulated as AS-0871/ASD tablets, following single-dose oral administration in healthy subjects. Part 2: To evaluate the safety and tolerability of AS-0871 following 14-day multiple-dose oral administration in healthy subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: To evaluate the relative bioavailability of AS-0871, formulated as AS-0871/DES capsules, under fasted and fed conditions in healthy subjects in comparison with the AS-0871 oral SDD suspension previously tested in trial C0871101. To evaluate the safety and tolerability of AS-0871, formulated as AS-0871/DES capsules, following single-dose oral administration under fasted and fed conditions in healthy subjects. Part 1a: To evaluate the relative bioavailability of AS-0871, formulated as AS-0871/ASD tablets, under fasted and fed conditions in healthy subjects in comparison with the AS-0871 oral SDD suspension previously tested in trial C0871101. To evaluate the safety and tolerability of AS-0871, formulated as AS-0871/ASD tablets, following single-dose oral administration under fasted and fed conditions in healthy subjects. Part 2: To evaluate the plasma PK of AS-0871 following 14-day multiple-dose oral administration in healthy subjects. To evaluate the PD (basophil response) of AS-0871 (in blood) following 14-day multiple-dose oral administration in healthy subjects. To perform correlation analysis of plasma concentration - PD (basophil response) of AS-0871. | — |
Countries
Netherlands
Outcome results
None listed