NL-OMON53402
Completed
Not Applicable
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. - Safety, PK and PD study of AS-0871 in healthy subjects
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Carna Biosciences, Inc.
- Enrollment
- 40
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 64 (—)
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.
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.
Investigators
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