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FC-12738 Safety and Tolerability in Healthy Adults
Phase 1
Recruiting
Research Sponsored by Neurodegenerative Disease Research Inc
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 at screening, day-1, pre-dose and 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, post-dose and follow-up visit on day 8.
Awards & highlights
Study Summary
This trial tests the safety, tolerability, and effectiveness of a potential drug for ALS in healthy adults and patients with ALS.
Who is the study for?
Healthy adults aged 18-65 and ALS patients aged 18-80 can join this trial. Participants must not be pregnant, breastfeeding, or planning pregnancy soon. They should agree to use effective contraception methods or practice true abstinence. No recent experimental drug use, significant blood loss, allergies to study drugs, serious infections, substance abuse or certain medical conditions are allowed.Check my eligibility
What is being tested?
The trial is testing FC-12738's safety and tolerability against a saline placebo in healthy participants and ALS patients. It's randomized and double-blind which means neither the researchers nor the participants know who gets the real drug versus placebo until after the results are collected.See study design
What are the potential side effects?
Since this is a first-in-human study for FC-12738, potential side effects aren't fully known yet but may include typical drug reactions like nausea, headaches, allergic responses or other unforeseen issues that will be closely monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at screening, day-1, pre-dose and 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, post-dose and follow-up visit on day 8.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at screening, day-1, pre-dose and 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, post-dose and follow-up visit on day 8.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Characterize the safety/tolerability of single-ascending-dose study of FC-12738 in healthy adult participants
Heart rate measure
Injection site reactions in normal participants
+6 moreSecondary outcome measures
Determine the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of single-ascending-dose study of FC-12738 in healthy adult participants
To determine the pharmacokinetic (PK) profiles in urine of single-ascending-dose study of FC-12738 in healthy adult participants
Other outcome measures
To assess the immunogenicity of single-ascending-dose study of FC-12738 in healthy adult participants
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SAD study in Healthy adult participantsExperimental Treatment1 Intervention
A total of 24 healthy adult participants will be enrolled, and then sequentially allocate to 3 planned dose cohorts (A1-A3): 4 mg, 8 mg and 16 mg, respectively.
Group II: PlaceboPlacebo Group1 Intervention
Placebo
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Neurodegenerative Disease Research IncLead Sponsor
Jason ArnoldStudy DirectorRho Worldwide
Lisa BuscoStudy DirectorRho Worldwide
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on any other immune system modifying treatments.I have had a solid organ or bone marrow transplant in the past.I have not lost more than 400 mL of blood for non-natural reasons in the last 2 months, nor do I plan to donate blood during or within a month after the trial.I haven't had major treatments or surgeries in the last 6 months and don't plan any during the trial.I do not have a history of liver disease or abnormal liver tests.My cancer, which can spread to other parts of the body, was diagnosed and treated within the last 5 years.I am a male willing to use contraception or practice abstinence during and 90 days after the study.I am between 18 and 65 years old and healthy, or I am between 18 and 80 years old.I do not have any major health issues that could interfere with the study.I have not had a psychiatric disorder, thoughts of suicide in the last 6 months, or any suicide attempts.I am not pregnant, planning to become pregnant, or breastfeeding during or within 3 months after the trial.My kidney function is below normal as per my latest tests.I have a heart condition that affects my heartbeat's timing or I take medication that can affect my heart's rhythm.I haven't had a serious infection in the last month.I am a healthy adult with a BMI between 18 and 26, and weigh at least 50 kg if male, or 45 kg if female.I am a woman not able to have children, using strong birth control, or not having sex.My recent health checks and tests show no significant issues.I am not taking any medication that could affect the study, as confirmed by the study team.
Research Study Groups:
This trial has the following groups:- Group 1: SAD study in Healthy adult participants
- 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.
Would I be eligible to join this research program?
"To be eligible for the clinical trial, applicants must demonstrate drug tolerance and lie between 18-65 years of age. The total number of patients to join is 24."
Answered by AI
Has the FDA sanctioned this survey of Seasonal Affective Disorder in healthy adults?
"Our company has assigned the safety of SAD study in Healthy adult participants a score of 1, as this is only Phase 1 trial and there are limited observations regarding its efficacy or security."
Answered by AI
Are any participants aged 40 or over participating in this exploration?
"This clinical trial is exclusively recruiting patients aged between 18 and 65. However, there are other trials available for those below or above the required age bracket - 9 studies target individuals under 18 while 31 cater to seniors over 65 years old."
Answered by AI
Are there any open spots for enrollment in this clinical test?
"As reflected in clinicaltrials.gov, recruitment for this medical trial is not open at the moment. This study was initially posted on October 1st 2023 and edited as recently as July 31st 2023. Despite its closure to new candidates, there are a plethora of other trials that are now actively enrolling patients across the country."
Answered by AI
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