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

Hypertriglyceridemia Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04419688
• Other study ID #: STT-01
• Status: Terminated
• Phase: Phase 1
• Start date: May 26, 2020
• Est. completion date: December 23, 2022

Study information

• Verified date: January 2023
• Source: Staten Biotechnology BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 93
• Est. completion date: December 23, 2022
• Est. primary completion date: December 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Covance Leeds Clinical Research Unit	Leeds	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Staten Biotechnology BV

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability	incidence and severity of adverse events	10 weeks
Secondary	AUC	Area under the PK curve	10-14 weeks
Secondary	Cmax	Maximum concentration	24 hours
Secondary	Half life	time to reduction in plasma levels by 50%	10-14 weeks