A Phase 1 Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IV SYNT001 in Healthy Volunteers.

Completed

Conditions: autoimmune disorder
blister disease
10003816

Registration Number: NL-OMON45830

Lead Sponsor: Syntimmune

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 32

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 <120 kg.;For more inclusion criteria, please refer to protocol

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety parameters including: Treatment Emergent Adverse Events (TEAE), adverse<br /><br>events (AE), Dose Limiting Toxicity (DLT), vital signs (blood pressure and<br /><br>pulse rate), physical examination, 12-lead ECG parameters and clinical<br /><br>laboratory values (hematology, total IgG, serum biochemistry, coagulation,<br /><br>urinalysis, urine microscopy).<br /><br>PK parameters including: t1/2, Cmax, Tmax, AUC0-24h, AUC0-Tlast, AUC0-*, and CL<br /><br>and Vd (if feasible).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>PD parameters including: absolute serum levels and percent change from baseline<br /><br>of total IgG, IgG subtypes (IgG1-4), immunoglobulin A (IgA), immunoglobulin M<br /><br>(IgM), albumin, and circulating immune complexes (CIC).<br /><br>PD immunogenicity parameters including: the presence of anti SYNT001 binding<br /><br>antibodies and neutralizing antibodies.</p><br>