A Phase 1 trial to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of AS-0871 and to evaluate the relative bioavailability and the food effect of new oral formulations of AS-0871 in healthy subjects.
- Conditions
- hives and rheumatoid arthritis10001708
- Registration Number
- NL-OMON53402
- Lead Sponsor
- Carna Biosciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part 1:<br /><br>To explore the effect of food on the plasma PK of AS-0871, formulated as<br /><br>AS-0871/DES capsules, following single-dose oral administration in healthy<br /><br>subjects.<br /><br><br /><br>Part 1a:<br /><br>To explore the effect of food on the plasma PK of AS-0871, formulated as<br /><br>AS-0871/ASD tablets, following single-dose oral administration in healthy<br /><br>subjects.<br /><br><br /><br>Part 2:<br /><br>To evaluate the safety and tolerability of AS-0871 following 14-day<br /><br>multiple-dose oral administration in healthy subjects.</p><br>
- Secondary Outcome Measures
Name Time Method