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OpenTrials
Completed

NCT Number: NCT01885624

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Emergency Hospital of Yaroslavl

Yaroslavl, 150003, Russia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAB08

Biological

monoclonal antibody

Primary outcomes

  1. Incidence of dose-limiting toxicity in every dose cohort

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

Sponsors and collaborators

Lead sponsor

Theramab LLC

Industry

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 25, 2013
Registry last updated
Feb 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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