CompletedPhase 1

A First-In-Human Study to Evaluate the Safety, Tolerability, and Efficacy of Si-544 in Adults With Atopic Dermatitis

Germany36 participantsStarted 2022-08-30

Plain-language summary

This is a multi-center, Phase 1b, double-blind, placebo-controlled, SAD and MAD, first-in-human study in subjects with mild to severe AD receiving si-544. The study consists of 2 parts, an SAD and an MAD part. In both parts, subjects will be treated in cohorts and will be randomized within each cohort to treatment with si-544 or placebo. Initially, 2 sentinel subjects will be treated (randomized to placebo or si-544) in each cohort.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Change (ie, starting anew, change in frequency, or change in drug substance) in standard systemic and topical therapy, or in immunosuppressive drug therapy within 4 weeks before Screening (for biologics such as dupilumab, the therapy may not be changed within 12 weeks before Screening), as judged by the investigator
. Known history of hypersensitivity to constituents or excipients in the pharmaceutical formulation of the IMP
. Uncontrolled hypertension or uncontrolled diabetes
. History of seizures
. Presence or history of paresthesia or neuropathy
. Clinically significant ECG abnormalities, as judged by the investigator
. Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease, as judged by the investigator

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adverse events (AEs)

Timeframe: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

Adverse events (AEs)

Timeframe: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

Change from Baseline in hematology parameter plateletes to all assessments during the study

Timeframe: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

Change from Baseline in hematology parameter plateletes to all assessments during the study

Timeframe: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

Change from Baseline in hematology parameter erythrocytes to all assessments during the study

Timeframe: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

Change from Baseline in hematology parameter erythrocytes to all assessments during the study

Timeframe: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

Trial details

NCT IDNCT05383378

SponsorselectION Therapeutics GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-01

View on ClinicalTrials.gov More Atopic Dermatitis trials

Plain-language summary

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Change (ie, starting anew, change in frequency, or change in drug substance) in standard systemic and topical therapy, or in immunosuppressive drug therapy within 4 weeks before Screening (for biologics such as dupilumab, the therapy may not be changed within 12 weeks before Screening), as judged by the investigator
. Known history of hypersensitivity to constituents or excipients in the pharmaceutical formulation of the IMP
. Uncontrolled hypertension or uncontrolled diabetes
. History of seizures
. Presence or history of paresthesia or neuropathy
. Clinically significant ECG abnormalities, as judged by the investigator
. Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease, as judged by the investigator