A Study of SYNT001 in Healthy Volunteers

Syntimmune

Status and phase: Completed; Early Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: SYNT001

Study type: Interventional

Funder types: Industry

Identifiers

NCT03643627

SYNT-101

Details and patient eligibility

About

This study is being done to compare the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of an intravenous (IV) formulation of SYNT001. This is the first-in-human (FIH) study of SYNT001.

Enrollment: 31 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

IInclusion Criteria:

Subjects must meet the following criteria to be included:

• Healthy as determined by comprehensive clinical assessment and clinical laboratory investigations
• Body mass index 18.5 to 30.0 kg/m2
• Must use medically acceptable contraception
• Willingness to complete all study measurements and assessments in compliance with the protocol

Exclusion Criteria:

Subjects meeting any of the following criteria are to be excluded:

• Past or present disease that is judged by the investigator to have the potential to interfere with the study procedures, compromise safety or affect the PK evaluations
• Subject unable or unwilling to comply with the protocol
• Any exposure to an investigational drug within the 30 days prior to screening
• Use of any tobacco or nicotine-containing products
• Abuse of alcohol
• Positive drug test or history of drug abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

31 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

1 mg/kg

Experimental group

Treatment:

Drug: SYNT001

3 mg/kg

Experimental group

Treatment:

Drug: SYNT001

10 mg/kg

Experimental group

Treatment:

Drug: SYNT001

30 mg/kg

Experimental group

Treatment:

Drug: SYNT001