Back to resultsA First in Human Study of STT-5058, an Antibody That Binds ApoC3
Primary Purpose
Hypertriglyceridemia
Status
Terminated
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
STT-5058
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypertriglyceridemia
Eligibility 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.
Sites / Locations
- Covance Leeds Clinical Research Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
STT-5058
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Safety and tolerability
incidence and severity of adverse events
Secondary Outcome Measures
AUC
Area under the PK curve
Cmax
Maximum concentration
Half life
time to reduction in plasma levels by 50%
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04419688
Brief Title
A First in Human Study of STT-5058, an Antibody That Binds ApoC3
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
recruitment failure
Study Start Date
May 26, 2020 (Actual)
Primary Completion Date
December 23, 2022 (Actual)
Study Completion Date
December 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Staten Biotechnology BV
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STT-5058
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
STT-5058
Intervention Description
Monoclonal Antibody STT-5058
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo to STT-5058
Primary Outcome Measure Information:
Title
Safety and tolerability
Description
incidence and severity of adverse events
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
AUC
Description
Area under the PK curve
Time Frame
10-14 weeks
Title
Cmax
Description
Maximum concentration
Time Frame
24 hours
Title
Half life
Description
time to reduction in plasma levels by 50%
Time Frame
10-14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Covance Leeds Clinical Research Unit
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS2 9LH
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A First in Human Study of STT-5058, an Antibody That Binds ApoC3
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