A Study to Evaluate the Effect of Injection Site on PK of Astegolimab in Healthy Subjects

A Phase 1, Open-Label, Randomized, Single Dose Study to Evaluate the Effect of Injection Site on the Pharmacokinetics of Astegolimab in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Astegolimab

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Covance Research Unit - Daytona
  • Texas
    • Dallas, Texas, United States, 75247
      • Covance Research Unit - Dallas
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance Clinical Research Unit, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A; Participants will receive one subcutaneous (SC) dose in the abdomen.	Drug: Astegolimab; Participants will receive one SC dose of astegolimab in the abdomen, upper arm, or thigh.
Experimental: Treatment B; Participants will receive one subcutaneous (SC) dose in the thigh.	Drug: Astegolimab; Participants will receive one SC dose of astegolimab in the abdomen, upper arm, or thigh.
Experimental: Treatment C; Participants will receive one subcutaneous (SC) dose in the upper arm.	Drug: Astegolimab; Participants will receive one SC dose of astegolimab in the abdomen, upper arm, or thigh.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Maximum serum concentration (Cmax) of astegolimab	Approximately 85 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Relative bioavailability (F%) for thigh injection 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
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
Incidence of anti-drug antibodies (ADAs)	Approximately 85 days

Collaborators and Investigators

• Sponsor: Genentech, Inc.
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2024
• Primary Completion (Actual): October 22, 2024
• Study Completion (Actual): October 22, 2024

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Tumor Necrosis Factor Inhibitors; Anti-Infective Agents; Anti-Inflammatory Agents; Antiviral Agents; Astegolimab
• Other Study ID Numbers: GP45400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No