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COMPLETEDPHASE1

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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single and Multiple Doses of PIPE_791 and Food Effect in Normal Healthy Volunteers

NCT05983939•Contineum Therapeutics

View on ClinicalTrials.gov

Summary

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).

Detailed Description

This is a randomized, double-blind study of PIPE-791 or placebo given as single and multiple escalating doses in normal healthy subjects. The study will be conducted in three parts: Part 1 will be a Single Ascending Dose (SAD) study enrolling approximately 48 subjects for a total duration of 6 weeks. Part 2 will be a Multiple Ascending Dose (MAD) study enrolling approximately 32 subjects for a total duration of 7 weeks, and part 3 will be a selected SAD cohort in a fed state to evaluate the effect of food on the bioavailability of PIPE-791, enrolling approximately 8 subjects for a duration of 6 weeks.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.

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.

Locations (1)

Worldwide Clinical Trials

San Antonio, Texas, United States

Key Dates

Start Date

June 26, 2023

Primary Completion Date

February 1, 2024

Completion Date

February 1, 2024

Last Updated

February 14, 2024

Enrollment

ACTUAL participants

Conditions

Multiple Sclerosis

Interventions

PIPE-791

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 14, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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