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siRNA
FXI-GalNAc-siRNA Safety and Tolerability in Healthy Subjects
Phase 1
Recruiting
Research Sponsored by Sirnaomics
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 145 days
Awards & highlights
Summary
This trial will test a new drug's safety, tolerability, how it's handled in the body, and its effects on healthy people.
Who is the study for?
Healthy men and women aged 18-55, with a BMI between 18 and 32 kg/m2, normal liver function tests, normal Factor XI levels, and no history of significant health issues. Women must not be pregnant or breastfeeding and agree to use two forms of contraception if they can become pregnant. Men also need to use barrier contraception.Check my eligibility
What is being tested?
The trial is testing the safety, how well tolerated it is, the pharmacokinetics (how the drug moves through the body), and pharmacodynamics (the effects of the drug) of a single subcutaneous dose of FXI-GalNAc-siRNA compared to a placebo in healthy participants.See study design
What are the potential side effects?
Specific side effects are not listed but generally could include reactions at injection site, potential changes in liver enzymes or blood clotting factors due to targeting Factor XI. Participants will be monitored for any adverse reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 145 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~145 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Apparent terminal elimination rate constant.
Area under the curve
Area under the curve from 0-infinity
+3 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Cohort 5Experimental Treatment2 Interventions
6 subjects injected with 400 mg dose of FXI-GalNAc-siRNA 2 subjects with Saline
Group II: Cohort 4Experimental Treatment2 Interventions
6 subjects injected with 200 mg dose of FXI-GalNAc-siRNA 2 subjects with Saline
Group III: Cohort 3Experimental Treatment2 Interventions
6 subjects injected with 100 mg dose of FXI-GalNAc-siRNA 2 subjects with Saline
Group IV: Cohort 2Experimental Treatment2 Interventions
6 subjects injected with 50 mg dose of FXI-GalNAc-siRNA 2 subjects with Saline
Group V: Cohort 1Experimental Treatment2 Interventions
6 subjects injected with 25 mg dose of FXI-GalNAc-siRNA 2 subjects with Saline
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
SirnaomicsLead Sponsor
11 Previous Clinical Trials
297 Total Patients Enrolled
Francois Lebel, MDStudy DirectorChief Medical Officer
5 Previous Clinical Trials
72 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received any vaccines (other than COVID-19 or flu) in the last 30 days and do not plan to during the study.I or my family have a history of blood vessel bulges or disorders.My blood pressure is higher than 140/90 mmHg.I haven't taken any drugs or supplements that affect heart rhythm recently.My hemoglobin levels are below the normal range for my gender.I haven't donated blood or plasma within the last 56 or 10 days, respectively.I agree to use effective contraception during and up to 140 days after the study.My cholesterol or triglyceride levels are very high.I am a woman who cannot have children due to surgery or menopause.My BMI is between 18 and 32.I am not pregnant, breastfeeding, or planning to become pregnant, and will use birth control if needed.I am between 18 and 55 years old.I or my family have a history of long QT syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 2
- Group 3: Cohort 3
- Group 4: Cohort 4
- Group 5: Cohort 5
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.
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