autoimmune disorder blister disease
Conditions
Interventions
SYNT001 and placebo solution (D5W).
Sponsors
Syntimmune
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Signed and dated informed consent form indicating the subject has read and understands the protocol and is willing to comply with all aspects of the study. Male or female subject (non-childbearing potential) between the ages of 18 and 55 years, inclusive, at the time of screening. Body mass index (BMI) range of 18.0 to 30.0 kg/m2 and body weight range of >50 kg to
Exclusion criteria
Exclusion criteria: Contraindication and/or history of allergic or anaphylactic reactions to study drugs or its excipients. Positive drug and alcohol test at Screening or on Day -1. Any vaccination within 2 weeks of Screening.;For more exclusion criteria, please refer to protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety parameters including: Treatment Emergent Adverse Events (TEAE), adverse events (AE), Dose Limiting Toxicity (DLT), vital signs (blood pressure and pulse rate), physical examination, 12-lead ECG parameters and clinical laboratory values (hematology, total IgG, serum biochemistry, coagulation, urinalysis, urine microscopy). PK parameters including: t1/2, Cmax, Tmax, AUC0-24h, AUC0-Tlast, AUC0-*, and CL and Vd (if feasible). | — |
Secondary
| Measure | Time frame |
|---|---|
| PD parameters including: absolute serum levels and percent change from baseline of total IgG, IgG subtypes (IgG1-4), immunoglobulin A (IgA), immunoglobulin M (IgM), albumin, and circulating immune complexes (CIC). PD immunogenicity parameters including: the presence of anti SYNT001 binding antibodies and neutralizing antibodies. | — |
Countries
Netherlands
Outcome results
None listed