Single Ascending Dose of FXI-GalNAc-siRNA in Healthy Subjects (NCT05844293) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Single Ascending Dose of FXI-GalNAc-siRNA in Healthy Subjects
United States, Canada40 participantsStarted 2023-05-16
Plain-language summary
The purpose of this study is to evaluate safety, tolerability, PK, and PD of SAD of FXI-GalNAc-siRNA administered SC to healthy subjects.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female subjects 18 to 55 years of age, inclusive, at the time of signing the informed consent form (ICF).
. Subjects must be in generally reasonable health with clinically insignificant screening and admission results (medical history, 12-lead electrocardiogram (ECG), physical examination, and laboratory tests), as determined by the Investigator.
. Subjects must have a body mass index (BMI) ≥ 18 kg/m2 or ≤ 32 kg/m2 at Screening and Day -1 (Admission).
. Subjects must have aspartate transaminase (AST), alanine transaminase (ALT), total bilirubin (TBIL), alkaline phosphatase (ALP), and glucose within upper limit of normal (ULN) range per reference laboratory reference ranges at Screening and Day -1 (Admission); one repeat laboratory analysis allowed per Investigator discretion.
. Subjects must have baseline Factor XI plasma levels within normal range as per testing laboratory requirements.
. Subjects must have prothrombin time (PT) and partial thromboplastin time (PTT) within the ULN range per reference laboratory reference ranges at Screening and Day -1 (Admission); one repeat laboratory analysis allowed per Investigator discretion.
. Women of childbearing potential must have a negative serum pregnancy test at Screening and negative urine pregnancy test at Day -1 (Admission), must not be actively breastfeeding, or planning to become pregnant during the study, and if not practicing abstinence from heterosexual activity that could result in conception (if this is the preferred and usual lifestyle of the subject), must agree to use 2 approved methods of birth control, during the study and for at least 140 days after study drug administration from the list below:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Condom plus diaphragm with spermicide started at least 28 days prior to dosing.
Exclusion criteria
. Patients with known diagnosis of Hemophilia C, Factor XI deficiency or another known bleeding disorder.
. Current or previous cancer except superficial forms of non-melanoma skin cancers that have been resolved with clear histology reporting; diabetes or known diagnosis of prediabetes; or any clinically significant cardiovascular (including ECG disturbances or history of rhythm disturbance/abnormality), endocrine, renal, hepatic, gastrointestinal, hematologic, respiratory, dermatological, neurological, psychiatric disorder that could be deemed by the investigator to interfere with study participation, or other disorders that the investigator deems could interfere with study participation.
. Hypertension, defined as blood pressure \> 140/90 mmHg (2 separate readings at least 15 minutes apart if first reading is not within normal range) at Screening and Day -1 (Admission).