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

NCT04419688 | Terminated Phase 1

• 1 other identifier: STT-01
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  incidence and severity of adverse events

  10 weeks

Secondary Outcomes (3)

• AUC

  10-14 weeks

• Cmax

  24 hours

• Half life

  10-14 weeks

Study Arms (2)

STT-5058

EXPERIMENTAL

Drug: STT-5058

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

STT-5058 DRUG

Monoclonal Antibody STT-5058

STT-5058

Placebo DRUG

Matching placebo to STT-5058

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Staten Biotechnology BV: lead

Study Sites (1)

Covance Leeds Clinical Research Unit

Leeds, West Yorkshire, LS2 9LH, United Kingdom

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 5, 2020
• Study Start: May 26, 2020
• Primary Completion: December 23, 2022
• Study Completion: December 23, 2022
• Last Updated: January 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)