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

NCT ID: NCT05383378

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-30
• Study Completion Date: 2023-11-01

Brief 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

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

si-544

Intervention Type: DRUG

Subcutaneous injection in the abdomen

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subcutaneous injection in the abdomen

Interventions

si-544

Subcutaneous injection in the abdomen

Intervention Type: DRUG

Placebo

Subcutaneous injection in the abdomen

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

SAD and MAD part

1. 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

2. Known history of hypersensitivity to constituents or excipients in the pharmaceutical formulation of the IMP

3. Uncontrolled hypertension or uncontrolled diabetes

4. History of seizures

5. Presence or history of paresthesia or neuropathy

6. Clinically significant ECG abnormalities, as judged by the investigator

7. Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease, as judged by the investigator

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

9. Known or active infection with Mycobacterium tuberculosis

10. Known or active infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus

11. Vaccination within 2 weeks before Screening and/or planned vaccination during the SAD part or the treatment period of the MAD part

12. Pregnancy

13. Any finding or medical condition prohibiting the inclusion in the study, as judged by the investigator

14. Current or previous (within 4 weeks before Screening) participation in another clinical study with an investigational medicinal product or medical device

15. Known or suspected abuse of alcohol, drugs, or medicinal products

16. Employee of the sponsor, or employee, or relative of the investigator

17. Use of prohibited medication

18. Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities

19. Legal incapacity or limited legal capacity

MAD part

20. Previous participation in the SAD part of this study with IMP dosing within 3 months before the planned first dosing of the MAD part.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FGK Clinical Research GmbH

INDUSTRY

Sponsor Role: collaborator

selectION Therapeutics GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Klostermann, Dr.

Role: STUDY_DIRECTOR

selectION Therapeutics GmbH

Locations

selectION Clinical Trial Site

Berlin, , Germany

selectION Clinical Trial Site

Hamburg, , Germany

selectION Clinical Trial Site

Magdeburg, , Germany

selectION Clinical Trial Site

Mainz, , Germany

selectION Clinical Trial Site

Wuppertal, , Germany

Countries

Germany

Other Identifiers

2021-003061-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SEL-001

Identifier Type: -

Identifier Source: org_study_id