A Study to Evaluate the Effect of Injection Site on PK of Astegolimab in Healthy Subjects
- Registration Number
- NCT06462118
- Lead Sponsor
- Genentech, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment A Astegolimab Participants will receive one subcutaneous (SC) dose in the abdomen. Treatment B Astegolimab Participants will receive one subcutaneous (SC) dose in the thigh. Treatment C Astegolimab Participants will receive one subcutaneous (SC) dose in the upper arm.
- Primary Outcome Measures
Name Time Method Maximum serum concentration (Cmax) of astegolimab Approximately 85 days Area under the curve from Hour 0 to the time of last measurable concentration (AUC0-t) of astegolimab Approximately 85 days AUC extrapolated to infinity (AUC0-infinity) of astegolimab Approximately 85 days
- Secondary Outcome Measures
Name Time Method Incidence of anti-drug antibodies (ADAs) Approximately 85 days Relative bioavailability (F%) for thigh injection of astegolimab Approximately 85 days Apparent volume of distribution during the terminal elimination phase (Vz/F) of astegolimab Approximately 85 days Time to maximum serum concentration (Tmax) of astegolimab Approximately 85 days F% for upper arm injection of astegolimab Approximately 85 days Half-life (T1/2) of astegolimab Approximately 85 days Apparent systemic clearance (CL/F) of astegolimab Approximately 85 days
Trial Locations
- Locations (3)
Covance Research Unit - Daytona
🇺🇸Daytona Beach, Florida, United States
Covance Clinical Research Unit, Inc
🇺🇸Madison, Wisconsin, United States
Covance Research Unit - Dallas
🇺🇸Dallas, Texas, United States