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BBP-671 for Propionic and Methylmalonic Acidemia
Phase 1
Waitlist Available
Research Sponsored by CoA Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 49 days
Awards & highlights
Study Summary
This trial is testing a new drug for people with Propionic Acidemia or Methylmalonic Acidemia to see if it is safe and effective.
Who is the study for?
This trial is for healthy adults aged 18-55 and patients with Propionic Acidemia (PA) or Methylmalonic Acidemia (MMA) aged 15-55. Participants must have a stable health condition, use birth control, and not be pregnant. Exclusions include recent drug/alcohol abuse, certain vaccine timings, organ transplants, infections requiring antibiotics within the last month, and specific medical histories.Check my eligibility
What is being tested?
The study tests BBP-671's safety and effects in comparison to a placebo. It aims to understand how the body processes it (pharmacokinetics/PK) and its impact on PA/MMA (pharmacodynamics/PD). The trial involves dose escalation to find the safest effective amount.See study design
What are the potential side effects?
While side effects are being studied as part of this trial's purpose, they may include typical drug reactions such as digestive discomforts, allergic responses or skin irritations. Specific side effects will be monitored closely due to the novel nature of BBP-671.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 49 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~49 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
BBP-671 concentration dependent change in change from baseline in QTcF
Incidence of adverse events following administration of BBP-671
Pharmacokinetic Assessments: AUC0-tau
+6 moreSecondary outcome measures
Food Effect: AUC
Food Effect: Cmax
Food Effect: Tmax
+1 moreTrial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: BBP-671 for SAD Food EffectExperimental Treatment1 Intervention
Eight (8) healthy male or female adult subjects will be randomized to receive BBP-671.
Group II: BBP-671 for SADExperimental Treatment1 Intervention
The SAD portion of the study will consist of up to 8 cohorts. Six (6) healthy male or female adult subjects will be randomized to receive BBP-671 per cohort (6:2 ratio, BBP-671:placebo).
Group III: BBP-671 for PA and MMA PatientsExperimental Treatment1 Intervention
Up to sixteen (16) patients with either PA or MMA will receive BBP-671.
Group IV: BBP-671 for MADExperimental Treatment1 Intervention
The MAD portion of the study will consist of up to 6 cohorts. Six (6) healthy male or female adult subjects will be randomized to receive BBP-671 per cohort (6:2 ratio, BBP-671:placebo).
Group V: Placebo for MADPlacebo Group1 Intervention
The MAD portion of the study will consist of up to 6 cohorts. Two (2) healthy male or female adult subjects will be randomized to receive matching placebo per cohort (6:2 ratio, BBP-671:placebo).
Group VI: Placebo for SADPlacebo Group1 Intervention
The SAD portion of the study will consist of up to 8 cohorts. Two (2) healthy male or female adult subjects will be randomized to receive matching placebo per cohort (6:2 ratio, BBP-671:placebo).
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
CoA Therapeutics Inc.Lead Sponsor
CoA Therapeutics, Inc., a BridgeBio companyLead Sponsor
Medical MonitorStudy ChairVP Clinical Development, CoA Therapeutics, Inc., a Bridgebio company
1,649 Previous Clinical Trials
979,646 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you are a healthy volunteer, you must have received the COVID-19 vaccine at least 14 days before starting the study drug.Healthy volunteers: Your kidney function is below a certain level.Your kidney function is not strong enough, with an eGFR below 60 mL/minute.If you have methylmalonic acidemia, your plasma MMA levels must be high.Healthy volunteers who have had a liver and/or kidney transplant cannot participate.Healthy volunteers with abnormal lab test results are not eligible.You have a history of alcohol or drug abuse within the past year.Healthy volunteers should not have any important heart-related history or problems found in their ECG test.Only people between the ages of 15 and 55 can participate in the study.You smoke or use nicotine products.You have tested positive for Hepatitis B, Hepatitis C, or HIV.You have had dry eye or eye surgery in the past, including LASIK surgery or radial keratotomy.You have abnormal lab test results not related to your condition.You have severe heart failure.You have received gene therapy for PA or MMA before joining the study.If you have a condition called PA, you cannot have had a liver or kidney transplant before. If you have a condition called MMA, you can have had a liver or kidney transplant before.You are currently taking certain medications that can interact with the study drug.Healthy volunteers should have a body mass index (BMI) between 18 and 32 kg/m^2.Patients with a body mass index (BMI) between 18 and 32 kg/m^2 are eligible.Healthy volunteers should not have had dry eye or eye surgery, including LASIK surgery.Healthy Volunteers: You have tested positive for Hepatitis B, Hepatitis C, or HIV.The study is looking for men and women between 18 and 55 years old who are in good health.You have given a large amount of blood within the last month.You have taken the study drug in another research study within the past 30 days.If you have had problems with alcohol or drug abuse in the past year, you cannot participate.If you have a rare disease called PA or MMA and have been vaccinated for COVID-19, your last dose or booster must have been at least 14 days before starting the study drug.You had a serious infection that needed strong antibiotics in the past 4 weeks or you have a current infection that makes it unsafe for you to join the study.Healthy volunteers: You have donated more than 450mL of blood or blood products in the last 30 days before taking the study drug.You must have a confirmed diagnosis of PA (propionic acidemia) or MMA (methylmalonic acidemia).
Research Study Groups:
This trial has the following groups:- Group 1: Placebo for MAD
- Group 2: BBP-671 for MAD
- Group 3: BBP-671 for SAD Food Effect
- Group 4: BBP-671 for PA and MMA Patients
- Group 5: BBP-671 for SAD
- Group 6: Placebo for SAD
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.
Is the participant criteria of this experiment restricted to those over 25?
"As per the criteria for inclusion, individuals aged 18 and above, but below 55 years old are eligible to join this clinical trial."
Answered by AI
Can BBP-671 be lawfully used in medical treatments?
"BBP-671's safety is rated 1 on our team at Power's scale due to its Phase 1 status, indicating a lack of evidence for both efficacy and security."
Answered by AI
How many participants are being accepted for this trial's protocol?
"Affirmative, the clinicaltrials.gov entry for this medical research project has been updated as recently as October 7th 2022; it was first posted on March 25th 2021 and is seeking 128 participants between two sites."
Answered by AI
Does this clinical experiment currently have any open slots for participants?
"Per the information provided on clinicaltrials.gov, this research is currently looking for participants. The trial was initially advertised on March 25th 2021 and went through its most recent update in October 7th 2022."
Answered by AI
Is it possible for me to join this trial?
"The current trial is seeking 128 individuals with propionicaciduria in the 18-55 age bracket and meeting certain physiological criteria. Specifically, participants must have a Body Mass Index between 18 to 32 kg/m^2; females need to hold negative pregnancy tests before receiving any medication while both genders are expected to use appropriate birth control measures. Furthermore, subjects should not possess noteworthy ocular impairments or ECG readings that could indicate health issues."
Answered by AI
What are the principal aims of this clinical examination?
"As per CoA Therapeutics, Inc., a BridgeBio company's report, the primary objective to be achieved over the 49-day period is Pharmacokinetic Assessments: AUC. Accompanying it are three secondary goals that focus on quantifying and summarising biomarker concentrations in whole blood, plasma and urine using liquid chromatography-tandem mass spectrometry techniques."
Answered by AI
Who else is applying?
What state do they live in?
New York
How old are they?
< 18
What portion of applicants met pre-screening criteria?
Met criteria
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