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OpenTrials
Completed

NCT Number: NCT06462118

A Study to Evaluate the Effect of Injection Site on PK 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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Research Unit - Daytona, Daytona Beach, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Astegolimab

Drug

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

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

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 17, 2024
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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