Clinical trial NCT05383378: A First-In-Human Study to Evaluate the Safety, Tolerability, and Efficacy of Si-544 in Adults With Atopic Dermatitis
Official title: A Multi-center, Phase 1b, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Efficacy of Si-544 in Adults With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopic Dermatitis
Keywords: Atopic Eczema
Neurodermatitis
Lead sponsor: selectION Therapeutics GmbH
Sponsor class: INDUSTRY
Collaborators: name: FGK Clinical Research GmbH
First posted: 2022-05-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The study consists of 2 parts, a single ascending dose (SAD) part, and a multiple ascending dose (MAD) part.
Primary purpose: TREATMENT

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.


Eligibility criteria: SAD and MAD part

1. Subject has the capacity for consenting, was informed about the nature, the scope, and the relevance of the clinical study, voluntarily agrees in participation and in the study provisions, and duly signed the informed consent form approved by the ethics committee before any study-related procedure.
2. Men and women aged ≥18 to 75 years
3. Willing and able to adhere to the protocol requirements
4. {deleted}
5. Women of childbearing potential must:

   1. have a negative pregnancy test (blood) at Screening.
   2. agree to use, and be able to comply with, highly effective measures of contraceptive control (failure rate less than 1% per year when used consistently and correctly) without interruption, from Screening through 30 days after the last IMP treatment.

   Reliable methods for this study are:

   i. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) ii. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) iii. intrauterine device iv. intrauterine hormone-releasing system v. bilateral tubal occlusion vi. vasectomized sexual partner (provided that the partner is the sole sexual partner of the woman of childbearing potential and has received medical assessment of the surgical success) vii. sexual abstinence (only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment) Abstinence is only accepted as true abstinence: when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence \[eg, calendar, ovulation, symptothermal, postovulation methods and withdrawal\] is not an acceptable method of contraception).

   c. agree to abstain from breast feeding during the study participation and for 90 days after the last IMP treatment.

   Postmenopausal (no menses for at least 1 year without alternative medical cause) or surgically sterile women (tubal ligation, hysterectomy, or bilateral oophorectomy) may be enrolled.
6. Men must practice true abstinence or agree to use a condom during sexual contact with a pregnant woman or a woman of childbearing potential for at least 90 days after the last IMP treatment, even after undergoing a successful vasectomy.

   SAD part only
7. Clinical diagnosis of mild to severe AD

   MAD part only
8. Clinical diagnosis of mild to severe AD with a SCORAD ≥15

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.

Primary outcomes:
measure: Adverse events (AEs)
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Adverse events (AEs)
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: Change from Baseline in hematology parameter leukocytes to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in hematology parameter differential leukocyte count to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in hematology parameter differential leukocyte count to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in hematology parameter hemoglobin to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in hematology parameter hemoglobin to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in hematology parameter hematocrit to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in hematology parameter hematocrit to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in hematology parameter mean corpuscular volume to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in hematology parameter mean corpuscular volume to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in hematology parameter mean corpuscular hemoglobin to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in hematology parameter mean corpuscular hemoglobin to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in hematology parameter mean corpuscular hemoglobin concentration to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in hematology parameter mean corpuscular hemoglobin concentration to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in alanine aminotransferase to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in alanine aminotransferase to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in aspartate aminotransferase to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in aspartate aminotransferase to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in gamma-glutamyl transferase to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in gamma-glutamyl transferase to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in alkaline phosphatase to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in alkaline phosphatase to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in total bilirubin to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in total bilirubin to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in unconjugated (indirect) bilirubin to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in unconjugated (indirect) bilirubin to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in conjugated (direct) bilirubin to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in conjugated (direct) bilirubin to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in blood urea nitrogen to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in blood urea nitrogen to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in creatinine to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in creatinine to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in uric acid to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in uric acid to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in estimated glomerular filtration rate to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in estimated glomerular filtration rate to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in blood biochemistry parameter sodium to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in blood biochemistry parameter sodium to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in blood biochemistry parameter potassium to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in blood biochemistry parameter potassium to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in blood biochemistry parameter magnesium to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in blood biochemistry parameter magnesium to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in blood biochemistry parameter chloride to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in blood biochemistry parameter chloride to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in blood biochemistry parameter inorganic phosphate to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in blood biochemistry parameter inorganic phosphate to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in blood biochemistry parameter calcium to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in blood biochemistry parameter calcium to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in blood biochemistry parameter creatine phosphokinase to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in blood biochemistry parameter creatine phosphokinase to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in blood biochemistry parameter amylase to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in blood biochemistry parameter amylase to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in blood biochemistry parameter lipase to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in blood biochemistry parameter lipase to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in blood biochemistry parameter total protein to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in blood biochemistry parameter total protein to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in blood biochemistry parameter albumin to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in blood biochemistry parameter albumin to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in blood biochemistry parameter glucose (non-fasting) to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in blood biochemistry parameter glucose (non-fasting) to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in blood biochemistry hemoglobin A1c to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in blood biochemistry hemoglobin A1c to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in blood biochemistry triglycerides to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in blood biochemistry triglycerides to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in blood biochemistry cholesterol to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in blood biochemistry cholesterol to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in blood biochemistry ferritin to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in blood biochemistry ferritin to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in blood biochemistry D-dimer to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in blood biochemistry D-dimer to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in blood biochemistry lactate dehydrogenase to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in blood biochemistry lactate dehydrogenase to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in blood biochemistry C-reative protein to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in blood biochemistry C-reative protein to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in blood coagulation partial thromboplastin time to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in blood coagulation partial thromboplastin time to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in blood coagulation parameter prothrombin time to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in blood coagulation parameter prothrombin time to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in blood coagulation parameter international normalized ratio (INR) all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in blood coagulation parameter international normalized ratio (INR) all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in urinalysis parameter pH to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in urinalysis parameter pH to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in urinalysis parameter leukocytes to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in urinalysis parameter leukocytes to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in urinalysis parameter nitrites to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in urinalysis parameter nitrites to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in urinalysis parameter blood to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in urinalysis parameter blood to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in urinalysis parameter protein to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in urinalysis parameter protein to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in urinalysis parameter glucose to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in urinalysis parameter glucose to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in urinalysis parameter ketones to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in urinalysis parameter ketones to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in urinalysis parameter urobilinogen to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in urinalysis parameter urobilinogen to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in urinalysis parameter bilirubin to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in urinalysis parameter bilirubin to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in 12-lead ECG parameter PR-interval to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in 12-lead ECG parameter PR-interval to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in 12-lead ECG parameter QRS-interval to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in 12-lead ECG parameter QRS-interval to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in 12-lead ECG parameter QT-interval to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in 12-lead ECG parameter QT-interval to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in 12-lead ECG parameter QTc[F]-interval to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in 12-lead ECG parameter QTc[F]-interval to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in peripheral oxygen saturation to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in peripheral oxygen saturation to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in blood pressure to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in blood pressure to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in heart rate to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in heart rate to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in respiration rate to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in respiration rate to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
measure: Change from Baseline in body temperature to all assessments during the study
timeFrame: SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)
measure: Change from Baseline in body temperature to all assessments during the study
timeFrame: MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)
Secondary outcomes:
measure: SAD part: Plasma concentration of free si-544 in blood plasma at Day 1
timeFrame: Day 1
measure: MAD part: Plasma concentration of free si-544 in blood plasma at Days 1 and 25
timeFrame: Day 1 and Day 25
measure: MAD part: Change from Baseline in number of T cells in peripheral blood at Day 29, and Weeks 8, 12, and 16
timeFrame: Day 1, Day 29, Week 8, Week 12, and Week 16 (last visit)
measure: MAD part: Change from Baseline in immunophenotyping of T-cell subsets at Day 29, and Weeks 8, 12, and 16
timeFrame: Day 1, Day 29, Week 8, Week 12, and Week 16 (last visit)
measure: MAD part: Change from Baseline in serum cytokine levels at Day 29, and Weeks 8, 12, and 16
timeFrame: Day 1, Day 29, Week 8, Week 12, and Week 16 (last visit)
measure: MAD part: Optional: Change from Baseline of expression levels of Kv1.3 vs KCa3.1 of effector memory T cells at Day 29, and Weeks 8, 12, and 16
timeFrame: Day 1, Day 29, Week 8, Week 12, and Week 16 (last visit)
measure: Change from Baseline in anti-drug antibodies against si-544 in serum at Day 29
timeFrame: Day 1 and Day 29
measure: Change from Baseline in inflamed areas using the body surface area index at Days 15 and 29, and Weeks 8, 12, and 16
timeFrame: Day 1, Day 15, Day 29, Week 8, Week 12, and Week 16 (last visit)
measure: Change from Baseline in atopic dermatitis (AD) severity by SCOring AD (SCORAD) at Days 15 and 29, and Weeks 8, 12, and 16
timeFrame: Day 1, Day 15, Day 29, Week 8, Week 12, and Week 16 (last visit)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: selectION Clinical Trial Site
city: Hamburg
country: Germany
facility: selectION Clinical Trial Site
city: Magdeburg
country: Germany
facility: selectION Clinical Trial Site
city: Mainz
country: Germany
facility: selectION Clinical Trial Site
city: Wuppertal
country: Germany
facility: selectION Clinical Trial Site
Study officials:
affiliation: selectION Therapeutics GmbH
name: Andreas Klostermann, Dr.
role: STUDY_DIRECTOR
References: