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

NCT ID: NCT04725175

Last Updated: 2021-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-26
• Study Completion Date: 2021-09-01

Brief Summary

This is a randomized, double-blind study of PIPE-307 or placebo 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 24 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-307, enrolling approximately 8 subjects from a selected SAD cohort for a duration of 6 weeks.

Detailed Description

This is a randomized, double-blind study of PIPE-307 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 24 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-307, enrolling approximately 8 subjects from a selected SAD cohort for a duration of 6 weeks. Safety will be assessed by periodic measurement of vital signs, physical examinations, electrocardiograms, blood laboratory analyses and occurrence of adverse events (AE).

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PIPE-307

Group Type: EXPERIMENTAL

PIPE-307

Intervention Type: DRUG

Single and multiple ascending oral doses of PIPE-307 tablets

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type: DRUG

Single and multiple ascending oral doses of matching Placebo tablets

Interventions

PIPE-307

Single and multiple ascending oral doses of PIPE-307 tablets

Intervention Type: DRUG

Placebo oral tablet

Single and multiple ascending oral doses of matching Placebo tablets

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Contineum Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Huhn, MD

Role: STUDY_DIRECTOR

Chief Medical Officer, Pipeline Therapeutics, Inc.

Locations

Linear Clinical Research

Nedlands, Western Australia, Australia

Countries

Australia

Other Identifiers

PIPE-307-101

Identifier Type: -

Identifier Source: org_study_id