A Study to Investigate the Safety, Tolerability, Immunogenicity, and Pharmacodynamics of VXX-401 Administered IM in Adult Participants
Hypercholesterolemia
About this trial
This is an interventional treatment trial for Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria: Male or female participants aged 18 to 75 years old, inclusive, at time of informed consent. LDL-C level = 2.59 mmol/L - 4.89mmol/L Body mass index between 18 and 35 kg/m2, inclusive at Screening, and with a minimum weight of 50 kg. Male participants and their partners of childbearing potential must commit to the use of highly effective contraceptives for the study duration and for at least 12 weeks after the last dose. Men must refrain from donating sperm during this same period. Female participants must be of nonchildbearing potential, or, for women of childbearing potential, must be willing to practice at least one form of highly effective contraception throughout the duration of the study and for at least 24 weeks following the last dose. Female participants must refrain from donating reproductive tissue during this same period. Exclusion Criteria: Subjects considered high risk or very high risk for ASCVD and requiring immediate treatment with LLT according to the clinical judgement of the investigator. History of confirmed anergy (i.e., not able to mount an immunological response) or history of immunization failure in the 5 years prior to the Screening Visit. Presence of fever >38°C or other signs or symptoms of acute disease within 1 week before the Screening and/or Visit 1; Screening and/or Visit 1 may be rescheduled at the discretion of the Investigator but must occur within the 4-week window. Known disturbance of coagulation or medication (see prohibited medications criterion below); bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture. Triglycerides > 5.65 mmol/L Has a history of clinically significant medical disorder or psychiatric conditions, which in the opinion of the investigator may compromise the participant's safety and ability to comply with study procedures or abide by study restrictions.
Sites / Locations
- Northern Beaches Clinical Research
- Sutherland Shire Clinical Research
- Emeritus Research
- University of the Sunshine Coast (USC)
- Emeritus Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Experimental
Experimental
VXX-401 Cohort A
VXX-401 Cohort B
VXX-401 Cohort C
VXX-401 Cohort D
Placebo Cohort A and C
Placebo Cohort B and D
VXX-401 Cohort E
VXX-401 Cohort F
VXX-401 100mcg administered by intramuscular (IM) injection at Week 0, Week 4, and Week 12
VXX-401 100mcg administered by intramuscular (IM) injection at Week 0, Week 4, Week 8 and Week 12
VXX-401 300mcg administered by intramuscular (IM) injection at Week 0, Week 4, and Week 12
VXX-401 300mcg administered by intramuscular (IM) injection at Week 0, Week 4, Week 8 and Week 12
Placebo administered by intramuscular (IM) injection at Week 0, Week 4, and Week 12
Placebo administered by intramuscular (IM) injection at Week 0, Week 4, Week 8 and Week 12
VXX-401 900mcg administered by intramuscular (IM) injection at Week 0. VXX-401 100 mcg administered by intramuscular (IM) injection at Week 4 and Week 12.
VXX-401 900mcg administered by intramuscular (IM) injection at Week 0. VXX-401 300 mcg administered by intramuscular (IM) injection at Week 4 and Week 12.