Primary objectives* To evaluate the safety and tolerability of multiple SYNT001 loading and maintenance doses in healthy subjects.* To determine the multiple dose pharmacokinetics (PK) of SYNT001 in healthy subjects.Secondary objectives* To evaluate…
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
SYNT001, a humanized, affinity-matured IgG4-kappa monoclonal antibody (mAb),
blocks immunoglobulin G (IgG) and IgG immune complex (IC) interactions with the
neonatal crystallizable fragment receptor (FcRn) and thereby inhibits the
varied roles played by FcRn in immune response.
Study objective
Primary objectives
* To evaluate the safety and tolerability of multiple SYNT001 loading and
maintenance doses in healthy subjects.
* To determine the multiple dose pharmacokinetics (PK) of SYNT001 in healthy
subjects.
Secondary objectives
* To evaluate the effect of SYNT001 on pharmacodynamic (PD) biomarkers
following multiple loading and maintenance doses in healthy subjects.
* To measure the immunogenicity of SYNT001 in healthy subjects following
multiple loading and maintenance doses in healthy subjects.
Exploratory objective
* Additional PK/PD and statistical analyses may be performed.
Study design
This is a Phase 1, single center, double-blind, placebo-controlled, randomized
study to evaluate the safety, tolerability, PK, and PD of multiple doses of
SYNT001 in healthy male and female (non-child-bearing potential) volunteers.
Intervention
SYNT001 and placebo solution (D5W).
Study burden and risks
The dosage levels of the study drug are based on a previous clinical trail
conducted by the sponsor. The risk to health at the chosen dose is limited, but
the patients may experience any of the side effects in the ICF or symptoms that
have not been reported before. Volunteer health is closely monitored during the
study to minimize the risks. If the volunteers experience side effects, the
investigator will treat them when necessary. If new information is available on
the safety of the study medication, the volunteers are informed as soon as
possible. The blood collection procedure is not dangerous.
Huntington Avenue 116, Suite 301
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US
Huntington Avenue 116, Suite 301
Boston MA 02116
US
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-003380-60-NL |
| CCMO | NL67453.056.18 |