ClinicalTrials.gg
RecruitingNCT07925983Updated Nov 9, 2026

A Study to Assess How Intravenous and Subcutaneous Administrations of Trosunilimab Move Through the Body of Healthy Adult Participants

A Phase 1 interventional study of Trosunilimab and Trosunilimab in Healthy Volunteer, sponsored by AbbVie. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by AbbVie · Phase 1, Interventional, and Basic science

Updated Nov 9, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteer

Keywords

  • Healthy Volunteer
03

In context

Lead sponsor

AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Body weight between 40 kg and 100 kg inclusive at screening and upon initial confinement.
  • (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 .
  • 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

Exclusion Criteria:

  • History: of epilepsy, any 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 abnormalities including the following:

    • Evidence of 2nd or 3rd degree atrioventricular (AV) block at screening visit or upon initial confinement.
    • 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 (including lymphoma and leukemia) other than successfully treated non- 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Arm 1: Trosunilimab IV

    Participants will receive an intravenous (IV) trosunilimab dose

    Drug: Trosunilimab

  • Active comparator
    Arm 2: Trosunilimab SC

    Participants will receive subcutaneous (SC) injection doses of trosunilimab

    Drug: Trosunilimab

Interventions

  • Subcutaneous (SC) Injection

    Also known as: ABBV-382

  • Intravenous (IV) Injection

    Also known as: ABBV-382

06

What researchers measure

Primary outcomes

  1. Maximum Serum Concentration (Cmax) of trosunilimab

    Cmax of trosunilimab

    Time frame: Up to 7 Days

  2. Time to Cmax (Tmax) of trosunilimab

    Tmax of trosunilimab

    Time frame: Up to 7 Days

  3. Concentration at Week 4 (Cwk4) of trosunilimab

    Cwk4 of trosunilimab

    Time frame: Week 4

  4. Area under the serum concentration-time curve from Week 0 to 4 (AUC0-4wk) of trosunilimab

    AUC0-4wk of trosunilimab

    Time frame: Weeks 0 to 4

  5. Number of Participants Experiencing Adverse Events

    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.

    Time frame: Up to 140 Days

07

Study locations

1 of 1 sites recruiting
  • Acpru /Id# 286224
    Grayslake, Illinois 60030, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07925983
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Nov 9, 2026
Start date
Oct 13, 2026
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Nov 9, 2026

Study contacts

ABBVIE CALL CENTER
Contact
abbvieclinicaltrials@abbvie.com
844-663-3742
ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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