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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

Study 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 weeks
Treatment ~ Varies
Follow Up ~145 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 145 days for reporting.

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 more

Trial 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

Find a Location

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

FXI-GalNAc-siRNA (siRNA) Clinical Trial Eligibility Overview. Trial Name: NCT05844293 — Phase 1
Factor XI Deficiency Research Study Groups: Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5
Factor XI Deficiency Clinical Trial 2023: FXI-GalNAc-siRNA Highlights & Side Effects. Trial Name: NCT05844293 — Phase 1
FXI-GalNAc-siRNA (siRNA) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05844293 — Phase 1

Frequently Asked Questions

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

Does this trial have an upper age limit for participants?

"As specified in the trial's admission requirements, participants must be over 18 years of age and under 55."

Answered by AI

Can the public currently participate in this research endeavor?

"Affirmative, the information located on clinicaltrials.gov suggests that this study is currently recruiting test subjects. It was initially posted and last modified on May 16th 2023; 40 participants are expected to be enrolled from 1 medical site."

Answered by AI

Has this therapy been sanctioned by the FDA?

"The safety of this course of treatment was scored a 1, as it is presently in the first phase of clinical trials and has only limited evidence supporting its efficacy."

Answered by AI

How many individuals are being enrolled in this research endeavor?

"Affirmative. According to the information publicly available on clinicaltrials.gov, this medical experiment is currently recruiting participants - with 40 patients needed from a single site. The trial was first made public on May 16th 2023 and has been updated since then."

Answered by AI

Am I eligible to be included in this clinical experiment?

"In order to be considered for this research study, applicants must have Factor Xi Deficiency and between the ages of 18-55. Recruitment is slated to involve a total of 40 individuals."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Single Ascending Dose of FXI-GalNAc-siRNA in Healthy Subjects
2023. "Single Ascending Dose of FXI-GalNAc-siRNA in Healthy Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05844293.
~0 spots leftby May 2024
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