Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of PIPE-791 and Food Effect in Healthy Volunteers

Exclusion Criteria

• •Has a current or recurrent disease that could affect the investigational medicinal product or affect clinical or laboratory assessments.
• •Experienced a significant systemic illness, as judged by the Investigator, within 30 days of the first dose.
• •Has a history of a significant medical, including hepatic and/or renal disease as outlined in the protocol, or psychiatric disorder that may require treatment or make the participant unlikely to fully complete the study or increase risk to the participant.
• •History of alcohol or other substance abuse within the 12 months prior to the dosing at the discretion of the Investigator.
• •Routine alcohol consumption meeting or exceeding protocol limits.
• •History of prior malignancy (except adequately treated non-melanoma skin cancer, carcinoma in-situ of the uterine cervix, ductal carcinoma in situ (DCIS), or localized prostate cancer).
• •Donated or lost more than 400 mL of blood within 56 days or plasma within 14 days prior to Screening.
• •Received an investigational agent within the last 30 days, prior to screening, or five half-lives of the prior investigational agent.
• •Use of any prescription medication, over-the-counter medication, vitamin or supplement, herbal or homeopathic preparation within 7 days or 5 half-lives prior to study drug administration, as determined by the Investigator. Hormone replacement therapy and hormonal contraception is permissible throughout the study.