A Study to Assess How Intravenous and Subcutaneous Administrations of Trosunilimab Move Through the Body of Healthy Adult Participants
A Phase 1 Study in Healthy Subjects to Assess Pharmacokinetics Following Intravenous and Subcutaneous Administration of Trosunilimab
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: ABBVIE CALL CENTER
- Phone Number: 844-663-3742
- Email: abbvieclinicaltrials@abbvie.com
Study Locations
-
-
Illinois
-
Grayslake, Illinois, United States, 60030
- Recruiting
- Acpru /Id# 286224
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Arm 1: Trosunilimab IV
Participants will receive an intravenous (IV) trosunilimab dose |
Subcutaneous (SC) Injection
Other Names:
Intravenous (IV) Injection
Other Names:
|
|
Active Comparator: Arm 2: Trosunilimab SC
Participants will receive subcutaneous (SC) injection doses of trosunilimab |
Subcutaneous (SC) Injection
Other Names:
Intravenous (IV) Injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum Serum Concentration (Cmax) of trosunilimab
Time Frame: Up to 7 Days
|
Cmax of trosunilimab |
Up to 7 Days
|
|
Time to Cmax (Tmax) of trosunilimab
Time Frame: Up to 7 Days
|
Tmax of trosunilimab |
Up to 7 Days
|
|
Concentration at Week 4 (Cwk4) of trosunilimab
Time Frame: Week 4
|
Cwk4 of trosunilimab |
Week 4
|
|
Area under the serum concentration-time curve from Week 0 to 4 (AUC0-4wk) of trosunilimab
Time Frame: Weeks 0 to 4
|
AUC0-4wk of trosunilimab |
Weeks 0 to 4
|
|
Number of Participants Experiencing Adverse Events
Time Frame: Up to 140 Days
|
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with the treatment. |
Up to 140 Days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: ABBVIE INC., AbbVie
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- M26-520
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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