Parexel Baltimore Early Phase Clinical Unit
Baltimore, Maryland, 21225, United States
NCT Number: NCT02148744
This first-in-human (FIH) study is a randomized, double-blinded, placebo-controlled, ascending dose study to investigate the safety, tolerability, and pharmacokinetics of XmAb7195 in adult healthy volunteers and in adult subjects with elevated IgE levels.
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Notify Me18 year–50 year
All sexes
Interventional
Phase 1
Baltimore, Maryland, 21225, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Part 1 and 2: Single IV infusion of XmAb7195 or placebo Part 3: Two-dose sequential IV infusion of XmAb7195 or placebo on Day 1 and Day 8
Time frame: Date of randomization up to Day 43
Number, type and severity of adverse events, vital signs, electrocardiogram (ECGs), laboratory tests, and physical examinations will be reported during the study from randomization up to Day 43
Time frame: Date of randomization up to Day 36
Number, type and severity of adverse events, vital signs, electrocardiogram (ECGs), laboratory tests, and physical examinations will be reported during the study from randomization up to Day 36
Time frame: Time of dosing up to Day 43
Pharmocokinetic (PK) analysis for levels of XmAb7195 will be determined in subjects blood from time of initial dosing up to Day 43
Time frame: Time of dosing up to Day 36
Presence of human anti-human antibodies will be assessed from time of dosing up to Day 36
Xencor, Inc.
Industry
A Randomized, Double-Blinded, Placebo-Controlled, Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of XmAb®7195
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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