A First in Human Study of STT-5058, an Antibody That Binds ApoC3

Staten Biotechnology

Status and phase

Terminated

Phase 1

Conditions

Hypertriglyceridemia

Treatments

Drug: Placebo

Drug: STT-5058

Study type

Interventional

Funder types

Industry

Identifiers

NCT04419688

STT-01

Details and patient eligibility

About

A 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

Full description

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

Enrollment

93 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.