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

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.

Study Overview

• Status: Completed
• Conditions: Adult Healthy Volunteers
• Intervention / Treatment: Biological: TAB08

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• Russian Federation
  • Yaroslavl, Russian Federation, 150003
    • Clinical Emergency Hospital of Yaroslavl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAB08; Single TAB08 i.v. infusion	Biological: TAB08; monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of dose-limiting toxicity in every dose cohort	From study drug infusion (Day 1) untill the end of study (Day 71/141)

Collaborators and Investigators

• Sponsor: Theramab LLC
• Investigators: Principal Investigator: Olga B Ershova, Prof., Clinical Emergency Hospital of Yaroslavl

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: June 19, 2013
• First Submitted That Met QC Criteria: June 20, 2013
• First Posted (Estimate): June 25, 2013

Study Record Updates

• Last Update Posted (Actual): February 15, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: healthy volunteers; TAB08
• Other Study ID Numbers: TAB08/HS/R1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO