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

Adult Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01885624
• Other study ID #: TAB08/HS/R1
• Status: Completed
• Phase: Phase 1
• First received: June 19, 2013
• Last updated: February 14, 2017
• Start date: November 2011
• Est. completion date: June 2013

Study information

• Verified date: February 2017
• Source: Theramab LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Adult Healthy Volunteers

Intervention

Biological:
• TAB08
monoclonal antibody

Locations

Country	Name	City	State
Russian Federation	Clinical Emergency Hospital of Yaroslavl	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
Theramab LLC

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose-limiting toxicity in every dose cohort		From study drug infusion (Day 1) untill the end of study (Day 71/141)