Phase I Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of of PIPE-307 and Food Effect in Healthy Volunteers

Recruitment & Eligibility

Inclusion Criteria

Male or female between 18 and 55 years of age (inclusive) at time of signing informed consent.
BMI is between 18.0 and 32.0 kg/m2
Male or female subjects with reproductive potential agree to comply with protocol-approved double barrier contraceptive method 30 days prior to 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 Investigator.

Exclusion Criteria

Has a current or recurrent diseases 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 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 I-situ of the uterine cervix, ductal carcinoma in situ (DCIS), or localized prostate cancer
Donated or lost more than 400ml of blood within 56 days or plasma within 14 days prior to screening
Received an investigational agent with the last 30 days prior to dosing or within 5 half-lives of the investigational agent
Use of any prescription medication, over-the-counter medication, vitamin or supplement, herbal or homeopathic preparations with 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

Study & Design

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo oral tablet	-
PIPE-307	PIPE-307	-

Primary Outcome Measures

Name	Time	Method
Safety: Treatment-Emergent Adverse Events (TEAE)	From baseline to 7 days post dosing for SAD cohorts and 21 days post dosing for MAD cohorts	Number of participants with TEAEs

Secondary Outcome Measures

Name	Time	Method
Safety: Cardiac repolarization using Fridericia-corrected QT interval (QTcF)	From baseline to 14 days post dose for SAD cohorts and 21 days post last dose for MAD cohorts	Change in mean QTcF
Pharmacokinetics (PK): Blood concentration levels of PIPE-307	From baseline to 14 days post dose for SAD cohorts and 21 days post last dose for MAD cohorts
PK: Urine concentration levels of PIPE-307	From baseline on day 1 through day 2 for SAD cohorts, and from baseline on day 1 though day 7 for the MAD cohorts
Exploratory: Impact of PIPE-307 on Cogstate	From baseline to day 2 for SAD cohorts and from baseline to day 7 for MAD cohorts	Cogstate tests have been designed, developed and validated to both identify and measure cognitive impairment, and to track or monitor cognitive changes. The tasks use novel visual and verbal stimuli to ensure assessment is cultural-neutral and not limited by a participant's level of education.

Recruitment & Eligibility