Official Title
Open Label Phase 1 Pharmacokinetics and Tolerability Study of Single TAB08 Administration in Healthy Volunteers
Phase
Phase 1Lead Sponsor
Theramab LLCStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Adult Healthy VolunteersIntervention/Treatment
tgn-1412 ...Study Participants
31The 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.
monoclonal antibody
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
