Open Label Phase 1 Pharmacokinetics & Tolerability Study of Single TAB08

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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.

See also
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NCT number	NCT01885624
Study type	Interventional
Source	Theramab LLC
Contact
Status	Completed
Phase	Phase 1
Start date	November 2011
Completion date	June 2013

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms