Title
A First in Human Study of STT-5058, an Antibody That Binds ApoC3
A Double-blind, Randomised, Placebo-controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple-ascending Doses of Intravenously Administered STT-5058 in Otherwise Healthy Subjects With Elevated Triglyceride Levels and Single-ascending and Multiple Doses of Subcutaneously Administered STT-5058 in Otherwise Healthy Subjects With Elevated Triglyceride Levels and Patient Volunteers With Hypertriglyceridemia.
Phase
Phase 1Lead Sponsor
Staten Biotechnology BVStudy Type
InterventionalStatus
TerminatedIndication/Condition
HypertriglyceridemiaIntervention/Treatment
STT-5058 ...Study Participants
93A First in Human Study of STT-5058, an Antibody That Binds ApoC3, investigating single and multiple ascending intravenous doses and ascending subcutaneous doses of STT-5058 in otherwise healthy volunteers with elevated triglyceride levels
The study is in five parts. Part A is up to 6 single ascending intravenous dose cohorts of STT-5058 in otherwise healthy volunteers with TRGs >150mg/dL. Part B is up to 4 multiple ascending intravenous dose cohorts of STT-5058 in otherwise healthy volunteers with TRGs >150mg/dL who will receive 3 doses at 2 week intervals. Part C will recruit a single cohort of patient volunteers with TRG >200mg/dL who will receive 3 doses at 2 week intervals of STT-5058. Part D will investigate up to 2 single ascending doses of subcutaneous STT-5058. Part E will recruit a single cohort of otherwise healthy volunteers with TRG > 150mg/dL to receive 4 doses subcutaneously of STT-5058 over 4 weeks
Monoclonal Antibody STT-5058
Matching placebo to STT-5058
Inclusion Criteria: in good health Able to comprehend and willing to sign an ICF and to abide by the study restrictions. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception Parts A, B and D BMI between 18 and 35 kg/m2 inclusive Fasting Triglycerides between 150 and 400mg/dL inclusive Part C Fasting Triglycerides between 200 and 400 mg/dL inclusive Fasting LDL-C between 70 and 160 mg/dL inclusive BMI between 18 and 40 kg/m2 Exclusion Criteria: significant history or clinical manifestation of metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator Confirmed (eg, 2 consecutive measurements) systolic blood pressure >150 or <90 mmHg, diastolic blood pressure >90 or <50 mmHg, and heart rate >90 or <40 beats per minute at Screening, Check-in, or prior to dosing on Day 1. History of alcoholism or drug/chemical abuse within 2 years prior to Check-in. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days or 5 half-lives (if known), whichever is longer, prior to dosing.
