NCT07925983 A Study to Assess How Intravenous and Subcutaneous Administrations of Trosunilimab Move Through the Body of Healthy Adult Participants
| NCT ID | NCT07925983 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | AbbVie |
| Condition | Healthy Volunteer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-10-13 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2026-10-13 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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 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.
Contact & Investigator
ABBVIE INC.
STUDY DIRECTOR
AbbVie
Frequently Asked Questions
Who can join the NCT07925983 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Healthy Volunteer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07925983 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07925983 currently recruiting?
Yes, NCT07925983 is actively recruiting participants. Contact the research team at abbvieclinicaltrials@abbvie.com for enrollment information.
Where is the NCT07925983 trial being conducted?
This trial is being conducted at Grayslake, United States.
Who is sponsoring the NCT07925983 clinical trial?
NCT07925983 is sponsored by AbbVie. The principal investigator is ABBVIE INC. at AbbVie. The trial plans to enroll 60 participants.