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CompletedNCT06462118Updated Jan 30, 2025

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

A Phase 1 interventional study of Astegolimab in Healthy Volunteers, sponsored by Genentech, Inc.. Completed at 3 sites in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-30.

Sponsored by Genentech, Inc. · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Oct 2024, 1 year 11 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
78 participants (actual)

Study arms

  • Experimental
    Treatment A

    Participants will receive one subcutaneous (SC) dose in the abdomen.

    Drug: Astegolimab

  • Experimental
    Treatment B

    Participants will receive one subcutaneous (SC) dose in the thigh.

    Drug: Astegolimab

  • Experimental
    Treatment C

    Participants will receive one subcutaneous (SC) dose in the upper arm.

    Drug: Astegolimab

Interventions

  • DrugAstegolimab

    Participants will receive one SC dose of astegolimab in the abdomen, upper arm, or thigh.

06

What researchers measure

Primary outcomes

  1. Area under the curve from Hour 0 to the time of last measurable concentration (AUC0-t) of astegolimab

    Time frame: Approximately 85 days

  2. AUC extrapolated to infinity (AUC0-infinity) of astegolimab

    Time frame: Approximately 85 days

  3. Maximum serum concentration (Cmax) of astegolimab

    Time frame: Approximately 85 days

Secondary outcomes

  1. Relative bioavailability (F%) for thigh injection of astegolimab

    Time frame: Approximately 85 days

  2. F% for upper arm injection of astegolimab

    Time frame: Approximately 85 days

  3. Half-life (T1/2) of astegolimab

    Time frame: Approximately 85 days

  4. Apparent systemic clearance (CL/F) of astegolimab

    Time frame: Approximately 85 days

  5. Apparent volume of distribution during the terminal elimination phase (Vz/F) of astegolimab

    Time frame: Approximately 85 days

  6. Time to maximum serum concentration (Tmax) of astegolimab

    Time frame: Approximately 85 days

  7. Incidence of anti-drug antibodies (ADAs)

    Time frame: Approximately 85 days

07

Study locations

3 sites
  • Covance Research Unit - Daytona
    Daytona Beach, Florida 32117, United States
  • Covance Research Unit - Dallas
    Dallas, Texas 75247, United States
  • Covance Clinical Research Unit, Inc
    Madison, Wisconsin 53704, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06462118
Lead sponsor
Genentech, Inc.
Responsible party
Sponsor
First posted
Jun 17, 2024
Start date
Jun 17, 2024
Primary completion
Oct 22, 2024
Completion
Oct 22, 2024
Last update
Jan 30, 2025

Study contacts

Clinical Trials
study director · Hoffmann-La Roche

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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