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

NCT01885624 | Completed Phase 1 DMC

• 1 other identifier: TAB08/HS/R1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adult Healthy Volunteers

Keywords

TAB08; healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Incidence of dose-limiting toxicity in every dose cohort

  From study drug infusion (Day 1) untill the end of study (Day 71/141)

Study Arms (1)

TAB08

EXPERIMENTAL

Single TAB08 i.v. infusion

Biological: TAB08

Interventions

TAB08 BIOLOGICAL

monoclonal antibody

TAB08

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Theramab LLC: lead

Study Sites (1)

Clinical Emergency Hospital of Yaroslavl

Yaroslavl, 150003, Russia

Location

MeSH Terms

Interventions

TGN-1412

Study Officials

• Olga B Ershova, Prof.

  Clinical Emergency Hospital of Yaroslavl

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: June 25, 2013
• Study Start: November 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 15, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)