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

Theramab

Status and phase

Completed

Phase 1

Conditions

Adult Healthy Volunteers

Treatments

Biological: TAB08

Study type

Interventional

Funder types

Industry

Identifiers

NCT01885624

TAB08/HS/R1

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

Male

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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