Your session is about to expire
← Back to Search
Plasmalogen Precursor
PPI-1011 for Healthy Adult Volunteers
Phase 1
Recruiting
Research Sponsored by MED-LIFE DISCOVERIES LP
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 days post-dose in single ascending dose subjects and up to 7 days post the lst dose in multiple ascending dose subjects.
Awards & highlights
Study Summary
This trial is testing a drug to treat an ultra rare genetic disorder. It's a safety & pharmacokinetics study to assess the drug's safety, tolerability, & PK in healthy people. 6 active:2 placebo per cohort of 8 subjects each.
Eligible Conditions
- Rhizomelic Chondrodysplasia Punctata
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 days post-dose in single ascending dose subjects and up to 7 days post the lst dose in multiple ascending dose subjects.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 days post-dose in single ascending dose subjects and up to 7 days post the lst dose in multiple ascending dose subjects.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Treatment-emergent adverse events as assessed by the CTCAE scale
Secondary outcome measures
Pharmacokinetics-AUC
Pharmacokinetics-Accumulation ratio (AR)
Pharmacokinetics-CL/F
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PPI-1011Experimental Treatment1 Intervention
Single Ascending: PPI-1011 at 10, 25, 50, 75 and 100 mg/kg. Multiple Dose: PPI-1011 dose to be based on SAD; duration 14 days; one dose daily.
Group II: PlaceboPlacebo Group1 Intervention
Placebo arm.
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
BioPharma Services, IncUNKNOWN
4 Previous Clinical Trials
138 Total Patients Enrolled
MED-LIFE DISCOVERIES LPLead Sponsor
1 Previous Clinical Trials
75 Total Patients Enrolled
1 Trials studying Rhizomelic Chondrodysplasia Punctata
75 Patients Enrolled for Rhizomelic Chondrodysplasia Punctata
Tara Smith, PhDStudy DirectorMED-LIFE DISCOVERIES LP
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a significant medical condition in your liver, kidneys, urinary system, stomach, heart, brain, lungs, hormone system, immune system, muscles, nerves, mental health, skin, or blood, unless the principal investigator or sub-investigator decides it's not significant.You have a history of HIV, Hepatitis B, or Hepatitis C.You have donated a certain amount of blood or plasma in the days leading up to the study, which may affect your participation.You have trouble swallowing the study drug, which comes in liquid form.You have tongue piercings or mouth jewelry.You have used supplements containing lipoic acid in the last 30 days or plan to use them during the study.You have a major physical or organ abnormality, as decided by the main doctor or another doctor helping with the study.You have tested positive for drugs, alcohol, or pregnancy.You are a healthy person who hasn't smoked for at least 6 months, and you are not pregnant or breastfeeding. If you are a woman, you are not able to have children or you have gone through menopause. You are between 18 and 65 years old.You can go without eating for at least 10 hours and eat regular meals.You have taken certain supplements like fish oil or krill oil in the last 30 days before the study.You have not had a menstrual period for at least one year, and your hormone levels confirm that you are post-menopausal.You have had a surgery to permanently prevent pregnancy for at least 6 months.Your body mass index (BMI) is between 18.5 and 30.0, and you weigh less than 91.0 kilograms.Your blood pressure, oxygen level, and heart rate need to be within specific ranges unless the study doctor says otherwise.Your recent lab test results are within the acceptable range or are not considered to be clinically significant by the study doctor.You have a history of alcohol or drug abuse, severe allergic reactions, or difficulties with blood sampling. You also have known allergies to specific substances or have had abnormal diet patterns recently.You have taken any medication to lower your cholesterol in the past 30 days.You have eaten grapefruit or pomelo in the 10 days before starting the study drug.You haven't had caffeine, poppy seeds, or alcohol for 48 hours before the study.
Research Study Groups:
This trial has the following groups:- Group 1: PPI-1011
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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 conditions to join this medical research study?
"To be eligible to join this clinical trial, patients must have rhizomelic chondrodysplasia punctata and lie between 18 to 65 years old. Up to 56 persons will be admitted into the trial."
Answered by AI
How many individuals have signed up to take part in this medical experiment?
"Affirmative. According to the clinicaltrials.gov portal, this study is currently recruiting individuals for participation. The trial was first publicized on May 29th 2023 and last edited on July 23rd of the same year. 56 people are needed from a single location."
Answered by AI
Does the age requirement for this clinical trial include individuals over 40 years old?
"This medical study is accessible to patients aged 18 and over, with an upper limit of 65 years old."
Answered by AI
Is this clinical trial still accepting participants?
"Reports on clinicaltrials.gov verify that this medical trial, initially posted in late May of 2023, is still actively recruiting suitable candidates. The information was most recently amended near the end of July 2023."
Answered by AI
Has the FDA approved PPI-1011 for use in humans?
"According to our team at Power, PPI-1011 achieved a safety rating of 1 due to the Phase 1 trial's limited evidence for both efficacy and safety."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger