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.

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

Study Overview

• Status: Terminated
• Conditions: Hypertriglyceridemia
• Intervention / Treatment: Drug: STT-5058; Drug: Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS2 9LH
      • Covance Leeds Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matching placebo to STT-5058
Experimental: STT-5058	Drug: STT-5058; Monoclonal Antibody STT-5058

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Staten Biotechnology BV

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2020
• Primary Completion (Actual): December 23, 2022
• Study Completion (Actual): December 23, 2022

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypertriglyceridemia
• Other Study ID Numbers: STT-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No