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

Prior treatment

• History of alcohol or other substance abuse within the 12 months prior to the dosing at the discretion of the Investigator.
• 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.

Other illness

• 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 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).

Lab values

• Has a current or recurrent disease that could affect the investigational medicinal product or affect clinical or laboratory assessments.

Other

• Routine alcohol consumption meeting or exceeding protocol limits.

• Male or female between 18 and 55 years of age (inclusive) at the time of signing informed consent.
• Male or female subjects with reproductive potential agree to comply with protocol-approved double barrier contraceptive method 30 days prior to the first dose and up to 90 days post last dose.
• Medically healthy with no clinically significant or relevant abnormalities in medical history, physical exam, vital signs, electrocardiogram (ECG), or laboratory evaluations (hematology, chemistry, and urinalysis) as assessed by the Investigatory.