← Back to Search

Other

PIPE-791 Safety Evaluation in Healthy Volunteers

Phase 1
Waitlist Available
Research Sponsored by Pipeline Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 14 days post dosing for sad cohorts and 14 days post dosing for mad cohorts
Awards & highlights

Study Summary

This trial will study the safety of a drug on humans through 3 parts. Vital signs & other tests will track safety and any AEs.

Who is the study for?
Healthy men and women aged 18-55 can join this trial if they agree to use double barrier contraception, have no significant health issues based on medical history, physical exams, ECGs, or lab tests. They must not consume alcohol excessively, take certain medications or supplements recently, donate blood/plasma too close to the study start date or have a history of substance abuse within the last year.Check my eligibility
What is being tested?
The trial is testing PIPE-791's safety at different doses compared to a placebo in healthy volunteers. It has three parts: single dose testing (SAD), multiple dose testing (MAD), and food effect on a selected single dose group. Participants' health will be monitored through vital signs, physical exams, ECGs and lab tests for adverse events.See study design
What are the potential side effects?
While specific side effects are not listed here as it's an initial test of PIPE-791 in humans; common side effects may include reactions at the injection site, headaches, nausea or other symptoms that will be closely monitored throughout the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 14 days post dosing for sad cohorts and 14 days post dosing for mad cohorts
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 14 days post dosing for sad cohorts and 14 days post dosing for mad cohorts for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety: Treatment-Emergent Adverse Events (TEAE)
Secondary outcome measures
Pharmacokinetics (PK): Blood concentration levels of PIPE-791
Pharmacokinetics: Urine concentration levels of PIPE-791
Safety: Cardiac repolarization using Fridericia-corrected QT interval (QTcF)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PIPE-791Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PIPE-791
2023
Completed Phase 1
~60

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Pipeline Therapeutics, Inc.Lead Sponsor
4 Previous Clinical Trials
272 Total Patients Enrolled
3 Trials studying Multiple Sclerosis
244 Patients Enrolled for Multiple Sclerosis
Contineum TherapeuticsLead Sponsor
4 Previous Clinical Trials
272 Total Patients Enrolled
3 Trials studying Multiple Sclerosis
244 Patients Enrolled for Multiple Sclerosis
Stephen Huhn, MDStudy DirectorPipeline Therapeutics
8 Previous Clinical Trials
325 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
238 Patients Enrolled for Multiple Sclerosis

Media Library

PIPE-791 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05983939 — Phase 1
Multiple Sclerosis Research Study Groups: PIPE-791, Placebo
Multiple Sclerosis Clinical Trial 2023: PIPE-791 Highlights & Side Effects. Trial Name: NCT05983939 — Phase 1
PIPE-791 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05983939 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the criteria to participate in this experiment?

"Participants in this trial must possess a diagnosis of multiple sclerosis, as well as be aged 18 to 55. Approximately 80 people are expected to take part in the study."

Answered by AI

Is the age range for this trial inclusive of individuals over 35 years old?

"The eligibility requirements for this clinical trial dictate that the minimum age of participation is 18 years and the maximum age must not exceed 55."

Answered by AI

What detrimental effects have been linked to PIPE-791?

"Due to the limited data supporting efficacy and safety, PIPE-791 was ranked a 1 on our internal scale of risk assessment."

Answered by AI

Is enrollment still open for participation in this trial?

"Data hosted on clinicaltrials.gov confirms that this endeavour, initially posted in late June 2023, is actively seeking participants. The trial has been revised as of the end of July 2023."

Answered by AI

How many individuals are engaging with this research project?

"Affirmative. According to information on clinicaltrials.gov, the medical trial in question is actively searching for 80 patients at a single location. This study was first posted on June 26th 2023 and last updated July 31st 2023."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of PIPE-791 and Food Effect in Healthy Volunteers
2023. "Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of PIPE-791 and Food Effect in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05983939.
~31 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top