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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04725175




Registration number
NCT04725175
Ethics application status
Date submitted
18/01/2021
Date registered
26/01/2021
Date last updated
3/11/2021

Titles & IDs
Public title
Phase I Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of of PIPE-307 and Food Effect in Healthy Volunteers
Scientific title
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single and Multiple Doses of PIPE-307 and Food Effect in Normal Healthy Volunteers
Secondary ID [1] 0 0
PIPE-307-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PIPE-307
Treatment: Drugs - Placebo oral tablet

Experimental: PIPE-307 -

Placebo comparator: Placebo -


Treatment: Drugs: PIPE-307
Single and multiple ascending oral doses of PIPE-307 tablets

Treatment: Drugs: Placebo oral tablet
Single and multiple ascending oral doses of matching Placebo tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety: Treatment-Emergent Adverse Events (TEAE)
Timepoint [1] 0 0
From baseline to 7 days post dosing for SAD cohorts and 21 days post dosing for MAD cohorts
Secondary outcome [1] 0 0
Safety: Cardiac repolarization using Fridericia-corrected QT interval (QTcF)
Timepoint [1] 0 0
From baseline to 14 days post dose for SAD cohorts and 21 days post last dose for MAD cohorts
Secondary outcome [2] 0 0
Pharmacokinetics (PK): Blood concentration levels of PIPE-307
Timepoint [2] 0 0
From baseline to 14 days post dose for SAD cohorts and 21 days post last dose for MAD cohorts
Secondary outcome [3] 0 0
PK: Urine concentration levels of PIPE-307
Timepoint [3] 0 0
From baseline on day 1 through day 2 for SAD cohorts, and from baseline on day 1 though day 7 for the MAD cohorts
Secondary outcome [4] 0 0
Exploratory: Impact of PIPE-307 on Cogstate
Timepoint [4] 0 0
From baseline to day 2 for SAD cohorts and from baseline to day 7 for MAD cohorts

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2021
Sample size
Target
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Contineum Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04725175
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Huhn, MD
Address 0 0
Chief Medical Officer, Pipeline Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04725175