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.

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04419688

Enrollment

Registered

2020-06-05

Start date

2020-05-26

Completion date

2022-12-23

Last updated

2023-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemia

Brief 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

Detailed 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

Interventions

DRUGSTT-5058

Monoclonal Antibody STT-5058

DRUGPlacebo

Matching placebo to STT-5058

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability	10 weeks	incidence and severity of adverse events

Secondary

Measure	Time frame	Description
AUC	10-14 weeks	Area under the PK curve
Cmax	24 hours	Maximum concentration
Half life	10-14 weeks	time to reduction in plasma levels by 50%

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026