Clinical trial NCT06462118: A Study to Evaluate the Effect of Injection Site on PK of Astegolimab in Healthy Subjects
Official title: A Phase 1, Open-Label, Randomized, Single Dose Study to Evaluate the Effect of Injection Site on the Pharmacokinetics of Astegolimab in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-17
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main objective is to study how astegolimab may behave in the body when injected subcutaneously into the abdomen, thigh, or upper arm in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Body weight of ≥50 kg to ≤110 kg with body mass index (BMI) range 18.0 to 30.0 kg/m2 (inclusive) at screening

Exclusion Criteria:

* History of significant hypersensitivity or severe allergic reaction, including anaphylaxis, to any drug compound, food, or other substance
* Any immunization or vaccination 14 days prior to the Check-in (Day -1) or plans to obtain any immunization or vaccination within 30 days after the Check-in
* Any surgical procedure (except for minor surgeries) within 28 days prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
* Donation of blood from 30 days prior to screening through study completion or end of trial, inclusive, or of plasma from 2 weeks prior to screening through study completion or end of trial, inclusive
* History of immunodeficiency, including but not limited to, human immunodeficiency virus (HIV) infection
* History of active or untreated latent tuberculosis
* History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer
* Unstable cardiac disease, myocardial infarction, or New York Heart Association Class 3 or 4 heart failure within 12 months prior to screening
* History or presence of clinically significant ECG abnormalities at screening or check-in (Day -1)
* Positive for Hepatitis B or Hepatitis C (HCV)
* Tattoo(s) or scarring at or near the site of injection (abdomen, front and middle thigh, or upper arm) or any other condition which may interfere with the injection site examination (as determined by the Investigator)

Primary outcomes:
measure: Area under the curve from Hour 0 to the time of last measurable concentration (AUC0-t) of astegolimab
timeFrame: Approximately 85 days
measure: AUC extrapolated to infinity (AUC0-infinity) of astegolimab
timeFrame: Approximately 85 days
measure: Maximum serum concentration (Cmax) of astegolimab
timeFrame: Approximately 85 days
Secondary outcomes:
measure: Relative bioavailability (F%) for thigh injection of astegolimab
timeFrame: Approximately 85 days
measure: F% for upper arm injection of astegolimab
timeFrame: Approximately 85 days
measure: Half-life (T1/2) of astegolimab
timeFrame: Approximately 85 days
measure: Apparent systemic clearance (CL/F) of astegolimab
timeFrame: Approximately 85 days
measure: Apparent volume of distribution during the terminal elimination phase (Vz/F) of astegolimab
timeFrame: Approximately 85 days
measure: Time to maximum serum concentration (Tmax) of astegolimab
timeFrame: Approximately 85 days
measure: Incidence of anti-drug antibodies (ADAs)
timeFrame: Approximately 85 days
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance Research Unit - Daytona
state: Florida
city: Dallas
country: United States
facility: Covance Research Unit - Dallas
state: Texas
city: Madison
country: United States
facility: Covance Clinical Research Unit, Inc
state: Wisconsin
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: