A Phase 1 Study in Healthy Subjects to Assess Pharmacokinetics Following Intravenous and Subcutaneous Administration of Trosunilimab

AbbVie

Summary

The objective of this study is to assess the pharmacokinetic (PK), immunogenicity and safety following trosunilimab SC and trosunilimab IV doses in healthy adult participants.

Eligibility

Age range: 18–65 years
Sex: All
Healthy volunteers: Yes

Detailed criteria

Inclusion Criteria: * Body weight between 40 kg and 100 kg inclusive at screening and upon initial confinement. * Body Mass Index (BMI) is \>= 18.0 to \<= 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters. * A condition of general good health, based upon the results of a medical history, PE, vital signs, laboratory profile and a 12-lead ECG. * A female must not be pregnant, or breastfeeding and is not considering becoming pregnant or donating eggs during the study or for approximately 125 days aft…

Interventions

Drug
Trosunilimab
Subcutaneous (SC) Injection
Drug
Trosunilimab
Intravenous (IV) Injection

Location

Acpru /Id# 286224
Grayslake, Illinois

A Phase 1 Study in Healthy Subjects to Assess Pharmacokinetics Following Intravenous and Subcutaneous Administration of Trosunilimab

Summary

Eligibility

Interventions

Location

Compensation

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Details

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