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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04419688
Recruitment Status : Terminated (recruitment failure)
First Posted : June 5, 2020
Last Update Posted : January 23, 2023
Sponsor:
Information provided by (Responsible Party):
Staten Biotechnology BV

Study Description
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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

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Drug: STT-5058 Drug: Placebo Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : May 26, 2020
Actual Primary Completion Date : December 23, 2022
Actual Study Completion Date : December 23, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: STT-5058 Drug: STT-5058
Monoclonal Antibody STT-5058
Placebo Comparator: Placebo Drug: Placebo
Matching placebo to STT-5058


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 10 weeks ]
    incidence and severity of adverse events


Secondary Outcome Measures :
  1. AUC [ Time Frame: 10-14 weeks ]
    Area under the PK curve

  2. Cmax [ Time Frame: 24 hours ]
    Maximum concentration

  3. Half life [ Time Frame: 10-14 weeks ]
    time to reduction in plasma levels by 50%


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04419688


Locations
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United Kingdom
Covance Leeds Clinical Research Unit
Leeds, West Yorkshire, United Kingdom, LS2 9LH
Sponsors and Collaborators
Staten Biotechnology BV
More Information
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Responsible Party: Staten Biotechnology BV
ClinicalTrials.gov Identifier: NCT04419688    
Other Study ID Numbers: STT-01
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: January 23, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases