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

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Staten Biotechnology BV

Criteria

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.