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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-17

Study Completion Date

2024-10-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Investigate Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Healthy Volunteers

NCT02596399

Healthy Volunteer

COMPLETED PHASE1

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD5148 in Healthy Adults

NCT06469151

Healthy Participants

COMPLETED PHASE1

This is a Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of AZD9742 After Single IV Doses in Healthy Subjects

NCT01030224

Healthy

COMPLETED PHASE1

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7049665 in Healthy Volunteers

NCT03221179

Healthy Volunteers

COMPLETED PHASE1

Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN3918 in Healthy Volunteers

NCT03115996

Healthy Volunteers

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment A

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

Group Type EXPERIMENTAL

Astegolimab

Intervention Type DRUG

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

Treatment B

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

Group Type EXPERIMENTAL

Astegolimab

Intervention Type DRUG

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

Treatment C

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

Group Type EXPERIMENTAL

Astegolimab

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Astegolimab

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes