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

• ClinicalTrials.gov Identifier: NCT04419688
• Recruitment Status: Terminated
• First Posted: June 5, 2020
• Last Update Posted: January 23, 2023
• Sponsor: Staten Biotechnology BV
• Information provided by (Responsible Party): Staten Biotechnology BV

Tracking Information

• First Submitted Date: June 3, 2020
• First Posted Date: June 5, 2020
• Last Update Posted Date: January 23, 2023
• Actual Study Start Date: May 26, 2020
• Actual Primary Completion Date: December 23, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 3, 2020)

Safety and tolerability [ Time Frame: 10 weeks ]

incidence and severity of adverse events

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 3, 2020)

• AUC [ Time Frame: 10-14 weeks ]
  Area under the PK curve
• Cmax [ Time Frame: 24 hours ]
  Maximum concentration
• Half life [ Time Frame: 10-14 weeks ]
  time to reduction in plasma levels by 50%

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.
• 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
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Hypertriglyceridemia

Intervention

• Drug: STT-5058
  Monoclonal Antibody STT-5058
• Drug: Placebo
  Matching placebo to STT-5058

Study Arms

• Experimental: STT-5058
  Intervention: Drug: STT-5058
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: October 5, 2022): 93
• Original Estimated Enrollment (submitted: June 3, 2020): 104
• Actual Study Completion Date: December 23, 2022
• Actual Primary Completion Date: December 23, 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT04419688
• Other Study ID Numbers: STT-01
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Staten Biotechnology BV
• Original Responsible Party: Same as current
• Current Study Sponsor: Staten Biotechnology BV
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Staten Biotechnology BV
• Verification Date: January 2023