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

Completed · Phase 1 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

This study will be conducted in three parts: Part 1 will be a Single Ascending Dose (SAD), Part 2 will be a Multiple Ascending Dose (MAD), and Part 3 will be a selected SAD cohort in a fed state. Safety will be assessed by periodic measurement of vital signs, physical examinations, electrocardiograms, blood laboratory analyses and occurrence of adverse events (AE).

Key facts

Study ID

NCT05983939

Run by

Contineum Therapeutics

People needed

56

Starts

2023-06-26

Expected to finish

2024-02-01

Last updated by the study team

2024-02-14

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Worldwide Clinical Trials — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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