SAD/MAD study in volunteers with moderate hypertriglyceridemia
Research type
Research Study
Full title
A Double-blind, Randomized, 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 Patient Volunteers with Moderate Hypertriglyceridemia and Single-ascending Doses of Subcutaneously Administered STT-5058 in Otherwise Healthy Subjects with Elevated Triglyceride Levels.
IRAS ID
270674
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Staten Biotechnology BV
Eudract number
2019-004248-31
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
19/NE/0264 , Rec ref.
Duration of Study in the UK
0 years, 10 months, 19 days
Research summary
This is a first-in-human, double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics [PK] (levels of the drug in bloodstream), and pharmacodynamics [PD] (effects of drug on body) of single- and multiple-ascending doses of intravenously administered STT-5058 in otherwise healthy volunteers (HV) with elevated triglycerides and patient volunteers with moderate hypertriglyceridemia. Single-ascending doses of subcutaneously administered STT-5058 will be administered to otherwise healthy subjects with elevated triglyceride (a type of fat) [TG] levels. Screening comprises 2 visits to assess fasting TG levels (Parts A, B, C, and D) and low-density lipoprotein cholesterol (LDL-C) levels (Part C only) during the first Screening visit and, if eligible, will complete screening procedures during the second Screening visit.
Part A comprises 5 sequential groups of HV, subjects in each group will receive a single intravenous dose on Day 1. Subjects will be resident from Day -1 (the day before dosing) until Day 3 of each treatment period. Planned dose levels will be 30 mg, 100 mg, 300 mg, 600 mg and 1200 mg.
Part B comprises 4 groups of HV in a multiple-dose sequential group design. Each subject will be dosed on Days 1, 15 and 29.
Part C comprises a single patient group. Each patient will be dosed intravenously on Days 1, 15 and 29. There will be an 8-hour fat-tolerance test the day before the first dose and the day after the last dose on Days -1 and Day 30.
Part D subjects participate in 1 treatment period and will be resident from Day -1 until Day 3. Subjects will receive a subcutaneous (under the skin) dose.
For all Parts, additional non-residential visits may be required based on the ongoing review of the safety, tolerability, PD and PK. For all subjects, dosing will be a single SC dose on Day 1.
REC name
North East - York Research Ethics Committee
REC reference
19/NE/0264
Date of REC Opinion
20 Apr 2020
REC opinion
Further Information Favourable Opinion