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

Phase 1TerminatedNCT04419688
Staten Biotechnology BV93 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

93

Conditions

Hypertriglyceridemia

Interventions

STT-5058DRUG

Monoclonal Antibody STT-5058

PlaceboDRUG

Matching placebo to STT-5058

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years
Medical Language ↔ Plain English
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.

Locations (1)

Covance Leeds Clinical Research Unit

Leeds, West Yorkshire, United Kingdom

Outcomes

Primary Outcomes

Safety and tolerability

incidence and severity of adverse events

Time frame: 10 weeks

Secondary Outcomes

AUC

Area under the PK curve

Time frame: 10-14 weeks

Cmax

Maximum concentration

Time frame: 24 hours

Half life

time to reduction in plasma levels by 50%

Time frame: 10-14 weeks

Data from ClinicalTrials.gov

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