Open Label Phase 1 Pharmacokinetics and Tolerability Study of Single TAB08 Administration in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-06-30

Brief Summary

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The purpose of this study is to assess safety and tolerability of ascending dosed of TAB08 after single i.v. infusion to the adult healthy volunteers. Additionally were assessed infusion speed tolerability, pharmacokinetics and pharmacodynamics of TAB08 after single i.v. infusion and to explore TAB mechanism-of-action biomarkers.

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Detailed Description

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Conditions

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Adult Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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TAB08

Single TAB08 i.v. infusion

Group Type EXPERIMENTAL

TAB08

Intervention Type BIOLOGICAL

monoclonal antibody

Interventions

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TAB08

monoclonal antibody

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Adult man aged from 18 to 40 years, who agreed to use adequate contraception.
* Body mass is at least 60 kg and BMI is within 20-27
* Volunteer is in good physical and mental health, as per his medical history and assessment results
* Volunteer's laboratory values are normal (or not clinically significant as per Investigator discretion) at screening, including baseline cytokines levels as per RESTORE test results
* Volunteer has signed the informed concent.

Exclusion Criteria

* Any chronic or relapsing illness in the medical history
* Any abnormal assessment or laboratory result at screening, which is clinically significant as per Investigator discretion
* Active tuberculosis at the time of screening
* Any acute illness at the time of study enrollment
* Any blood donation within 4 weeks before Study Day 1
* Positive result for HBsAG, Hepatitis C, HIV
* Continuous use af any medications
* Use of any medications within 72 hours before study drug infusion
* Use of an investigational treatment within 4 weeks before screening, or within a period of 5 half-lives of the investigational treatment, whichever is longer
* High inflammatory cytokines levels as per RESTORE test results after ex vivo PBMC testing

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes