Status:
TERMINATED
A First in Human Study of STT-5058, an Antibody That Binds ApoC3
Lead Sponsor:
Staten Biotechnology BV
Conditions:
Hypertriglyceridemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 volunt...
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 intraveno...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2022
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT04419688
Start Date
May 26 2020
End Date
December 23 2022
Last Update
January 23 2023
Active Locations (1)
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1
Covance Leeds Clinical Research Unit
Leeds, West Yorkshire, United Kingdom, LS2 9LH