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

NCT05383378 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-11-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

si-544

Subcutaneous injection in the abdomen

DRUG

Placebo

Subcutaneous injection in the abdomen

Sponsors & Collaborators

  • FGK Clinical Research GmbH

    collaborator INDUSTRY

  • selectION Therapeutics GmbH

    lead INDUSTRY

Principal Investigators

  • Andreas Klostermann, Dr. · selectION Therapeutics GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-30
Primary Completion
2023-11-01
Completion
2023-11-01

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05383378 on ClinicalTrials.gov