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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01885624

Enrollment

Registered

2013-06-25

Start date

2011-11-30

Completion date

2013-06-30

Last updated

2017-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Healthy Volunteers

Keywords

TAB08, healthy volunteers

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.

Interventions

BIOLOGICALTAB08

monoclonal antibody

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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)

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026