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 range18 Years – 75 Years

SexALL

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
✕. Presence of acute infection within 7 days before Screening, as judged by the investigator

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)

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

Timeframe: SAD part: Between Day 1 (IMP injection) and Day 8 (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 range18 Years – 75 Years

SexALL

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
✕. Presence of acute infection within 7 days before Screening, as judged by the investigator