A First in Human Study of STT-5058, an Antibody That Binds ApoC3 (NCT04419688) | Clinical Trial Compass
TerminatedPhase 1
A First in Human Study of STT-5058, an Antibody That Binds ApoC3
Stopped: recruitment failure
United Kingdom93 participantsStarted 2020-05-26
Plain-language summary
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
Who can participate
Age range18 Years – 65 Years
SexALL
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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.