Status:
COMPLETED
Open Label Phase 1 Pharmacokinetics and Tolerability Study of Single TAB08 Administration in Healthy Volunteers
Lead Sponsor:
Theramab LLC
Conditions:
Adult Healthy Volunteers
Eligibility:
MALE
18-40 years
Phase:
PHASE1
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 tolerab...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01885624
Start Date
November 1 2011
End Date
June 1 2013
Last Update
February 15 2017
Active Locations (1)
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1
Clinical Emergency Hospital of Yaroslavl
Yaroslavl, Russia, 150003