Clinical trial NCT04419688: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hypertriglyceridemia
Lead sponsor: Staten Biotechnology BV
Sponsor class: INDUSTRY
First posted: 2020-06-05
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Safety and tolerability
timeFrame: 10 weeks
Secondary outcomes:
measure: AUC
timeFrame: 10-14 weeks
measure: Cmax
timeFrame: 24 hours
measure: Half life
timeFrame: 10-14 weeks
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Leeds Clinical Research Unit
state: West Yorkshire
Study officials:
References: