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

NCT04725175 | Completed Phase 1 DMC

• 1 other identifier: PIPE-307-101
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Safety: Treatment-Emergent Adverse Events (TEAE)

  Number of participants with TEAEs

  From baseline to 7 days post dosing for SAD cohorts and 21 days post dosing for MAD cohorts

Secondary Outcomes (4)

• 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

• 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

Study Arms (2)

PIPE-307

EXPERIMENTAL

Drug: PIPE-307

Placebo

PLACEBO COMPARATOR

Drug: Placebo oral tablet

Interventions

PIPE-307 DRUG

Single and multiple ascending oral doses of PIPE-307 tablets

PIPE-307

Placebo oral tablet DRUG

Single and multiple ascending oral doses of matching Placebo tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Contineum Therapeutics: lead

Study Sites (1)

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Stephen Huhn, MD

  Chief Medical Officer, Pipeline Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: All roles are masked with the exception of the pharmacist/dose preparer.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 26, 2021
• Study Start: February 26, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: November 3, 2021

Record last verified: 2020-11

Locations

AU (1)