Clinical trial NCT06402513: A Study in Healthy Adult Participants to Assess the Pharmacokinetics, Immunogenicity, Safety, and Tolerability of a Ravagalimab Subcutaneous Formulation in a Pre-Filled Syringe
Official title: A Phase 1 Study in Healthy Adult Subjects to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability of a Ravagalimab Subcutaneous Formulation in a Pre-Filled Syringe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
Ravagalimab
ABBV-323
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-05-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to assess the pharmacokinetics, immunogenicity, safety, and tolerability, of subcutaneous formulation of ravagalimab in a pre-filled syringe in healthy adult participants.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m\^2 after rounding to the tenth decimal at screening.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.

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 using any over the counter and/or prescription medication, vitamins and/or herbal supplements, with the exception contraceptives or hormonal replacement therapies for females, on a regular basis.
* History of any clinically significant sensitivity or allergy to any medication or food.
* No prior exposure to ravagalimab
* Participant using any medications, vitamins, and/or herbal supplements within the 2-week period or 5 half-lives (whichever is longer) prior to study drug administration.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Approximately up to 71 days
measure: Time to Maximum Observed Plasma Concentration (Tmax)
timeFrame: Approximately up to 71 days
measure: Apparent Terminal Phase Elimination Rate Constant (β)
timeFrame: Approximately up to 71 days
measure: The Terminal Phase Elimination Half-Life (t1/2)
timeFrame: Approximately up to 71 days
measure: The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
timeFrame: Approximately up to 71 days
measure: The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
timeFrame: Approximately up to 71 days
measure: Number of Anti-drug antibody (ADA) Titers
timeFrame: Approximately up to 71 days
measure: Number of Participants with Adverse Events
timeFrame: Approximately up to 85 days
Secondary outcomes:
Other outcomes:
Locations:
city: Grayslake
country: United States
facility: Acpru /Id# 265325
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: