How trosunilimab moves through the body after IV and SC doses in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional study examines the pharmacokinetics, immunogenicity, and safety of trosunilimab when given by IV and SC routes in healthy adult participants. The trial compares how the drug is absorbed, distributed, metabolized, and eliminated, while monitoring any immune responses and adverse events. Eligible participants must be healthy, within specified weight and BMI ranges, and nonpregnant, with exclusions for certain medical histories and ECG abnormalities. The study is sponsored by AbbVie with a site in Grayslake, Illinois. Primary outcomes focus on PK profiles and safety signals to inform future dosing strategies.

Why it matters

Who can join: the full rules

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 after the last dose of study treatment.

Exclusion Criteria:

* History: of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
* Participant has any clinically significant ECG abnormalities including the following:

  * Evidence of 2nd or 3rd degree atrioventricular (AV) block at screening visit or upon initial confinement.
  * QT interval corrected for heart rate (QTc) using Fridericia's correction formula (QTcF) ˃ 450 msec (males) or ˃ 460 msec (females) at screening visit or upon initial confinement.
* History of any clinically significant sensitivity or allergy to any medication or food.
* Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.
* History or evidence of active tuberculosis (TB) disease or latent TB infection.
* History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study treatment.

Where it's running

• Acpru /Id# 286224
  Grayslake, Illinois, United States Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.