Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
SAD and MAD part
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.
Men and women aged ≥18 to 75 years
Willing and able to adhere to the protocol requirements
{deleted}
Women of childbearing potential must:
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.
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
Clinical diagnosis of mild to severe AD
MAD part only
Clinical diagnosis of mild to severe AD with a SCORAD ≥15
Exclusion Criteria:
SAD and MAD part
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
Known or active infection with Mycobacterium tuberculosis
Known or active infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
Vaccination within 2 weeks before Screening and/or planned vaccination during the SAD part or the treatment period of the MAD part
Pregnancy
Any finding or medical condition prohibiting the inclusion in the study, as judged by the investigator
Current or previous (within 4 weeks before Screening) participation in another clinical study with an investigational medicinal product or medical device
Known or suspected abuse of alcohol, drugs, or medicinal products
Employee of the sponsor, or employee, or relative of the investigator
Use of prohibited medication
Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
Legal incapacity or limited legal capacity
MAD part
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 purpose
Allocation
Interventional model
Masking
36 participants in 2 patient groups, including a placebo group
Loading...
Central trial contact
Andreas Klostermann, Dr.
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal