Recruiting
Phase 1

Trosunilimab

Sponsor:

AbbVie

Code:

NCT07925983

Conditions

Healthy Volunteer

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Trosunilimab

Trosunilimab

Study Details

Brief 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.

Conditions

Healthy Volunteer

Study ID

NCT07925983

Start date

Oct 13, 2026

Status verified date

Nov, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Arm 1: Trosunilimab IV

Participants will receive an intravenous (IV) trosunilimab dose

active comparator: Arm 2: Trosunilimab SC

Participants will receive subcutaneous (SC) injection doses of trosunilimab

Interventions

Trosunilimab

Subcutaneous (SC) Injection

Trosunilimab

Intravenous (IV) Injection

Primary outcome measure

  • Maximum Serum Concentration (Cmax) of trosunilimab [ Time Frame: Up to 7 Days ]
  • Time to Cmax (Tmax) of trosunilimab [ Time Frame: Up to 7 Days ]
  • Concentration at Week 4 (Cwk4) of trosunilimab [ Time Frame: Week 4 ]
  • Area under the serum concentration-time curve from Week 0 to 4 (AUC0-4wk) of trosunilimab [ Time Frame: Weeks 0 to 4 ]
  • Number of Participants Experiencing Adverse Events [ Time Frame: Up to 140 Days ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Acpru /Id# 286224

Recruiting

Grayslake, Illinois, United States, 60030

More Information

Sponsor

AbbVie

Last update posted

Nov 9, 2026

Last verified

Nov, 2026

Keywords

  • Healthy Volunteer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-10. This information was provided to ClinicalTrials.gov by AbbVie on 2026-11-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.