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

Phase 1

Terminated

• Conditions: Hypertriglyceridemia
• Interventions: Drug: Placebo; Drug: STT-5058

• Registration Number: NCT04419688
• Lead Sponsor: Staten Biotechnology BV

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 Timeline

• Study Start: 2020-05-26
• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-03
• Study First Posted: 2020-06-05
• Primary Completion: 2022-12-23
• Study Completion: 2022-12-23
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-19
• Last Update Posted: 2023-01-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 93

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
STT-5058	STT-5058	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	10 weeks	incidence and severity of adverse events

Secondary Outcome Measures

Name	Time	Method
AUC	10-14 weeks	Area under the PK curve
Cmax	24 hours	Maximum concentration
Half life	10-14 weeks	time to reduction in plasma levels by 50%

Trial Locations

Locations (1)

Covance Leeds Clinical Research Unit; 🇬🇧 Leeds, West Yorkshire, United Kingdom