Healthy VolunteersPhase 1NCT06462118
A Study to Evaluate the Effect of Injection Site on PK of Astegolimab in Healthy Subjects
A Phase 1 study testing Astegolimab in people with Healthy Volunteers, run by Genentech, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Astegolimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Jun 2024to 22 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight of ≥50 kg to ≤110 kg with body mass index (BMI) range 18.0 to 30.0 kg/m2 (inclusive) at screening
Who cannot join
- 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
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- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Covance Research Unit - Dallas
Dallas, Texas, 75247
Covance Research Unit - Daytona
Daytona Beach, Florida, 32117
Covance Clinical Research Unit, Inc
Madison, Wisconsin, 53704
About this study
Official 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
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.
- Conditions
- Healthy Volunteers
- Being tested
- Astegolimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AstegolimabDrug
Participants will receive one SC dose of astegolimab in the abdomen, upper arm, or thigh.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Participants will receive one subcutaneous (SC) dose in the abdomen. Receives: Drug: Astegolimab |
| Treatment B | Experimental | Participants will receive one subcutaneous (SC) dose in the thigh. Receives: Drug: Astegolimab |
| Treatment C | Experimental | Participants will receive one subcutaneous (SC) dose in the upper arm. Receives: Drug: Astegolimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve from Hour 0 to the time of last measurable concentration (AUC0-t) of astegolimab
Measured: Approximately 85 days
AUC extrapolated to infinity (AUC0-infinity) of astegolimab
Measured: Approximately 85 days
Maximum serum concentration (Cmax) of astegolimab
Measured: Approximately 85 days
Secondary outcomes (7)
Relative bioavailability (F%) for thigh injection of astegolimab
Measured: Approximately 85 days
F% for upper arm injection of astegolimab
Measured: Approximately 85 days
Half-life (T1/2) of astegolimab
Measured: Approximately 85 days
Apparent systemic clearance (CL/F) of astegolimab
Measured: Approximately 85 days
Apparent volume of distribution during the terminal elimination phase (Vz/F) of astegolimab
Measured: Approximately 85 days
Time to maximum serum concentration (Tmax) of astegolimab
Measured: Approximately 85 days
Incidence of anti-drug antibodies (ADAs)
Measured: Approximately 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start17 Jun 2024
- Primary completion22 Oct 2024
- Study completion22 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462118
- Sponsor's protocol ID
- GP45400
- Status last verified
- Jan 2025
- First submitted
- 12 Jun 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06462118
- Acronym / sponsor ID
- GP45400
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 22 Oct 2024 (actual)
- Study completion
- 22 Oct 2024 (actual)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: AstegolimabParticipants will receive one subcutaneous (SC) dose in the abdomen. |
| Treatment B | Experimental | Drug: AstegolimabParticipants will receive one subcutaneous (SC) dose in the thigh. |
| Treatment C | Experimental | Drug: AstegolimabParticipants will receive one subcutaneous (SC) dose in the upper arm. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body weight of ≥50 kg to ≤110 kg with body mass index (BMI) range 18.0 to 30.0 kg/m2 (inclusive) at screening
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AstegolimabParticipants will receive one SC dose of astegolimab in the abdomen, upper arm, or thigh. | Drug | Treatment A, Treatment B, Treatment C |
Primary outcome
Area under the curve from Hour 0 to the time of last measurable concentration (AUC0-t) of astegolimab
Time frame: Approximately 85 days
AUC extrapolated to infinity (AUC0-infinity) of astegolimab
Time frame: Approximately 85 days
Maximum serum concentration (Cmax) of astegolimab
Time frame: Approximately 85 days
7 secondary outcomes
Relative bioavailability (F%) for thigh injection of astegolimab
Time frame: Approximately 85 days
F% for upper arm injection of astegolimab
Time frame: Approximately 85 days
Half-life (T1/2) of astegolimab
Time frame: Approximately 85 days
Apparent systemic clearance (CL/F) of astegolimab
Time frame: Approximately 85 days
Apparent volume of distribution during the terminal elimination phase (Vz/F) of astegolimab
Time frame: Approximately 85 days
Time to maximum serum concentration (Tmax) of astegolimab
Time frame: Approximately 85 days
Incidence of anti-drug antibodies (ADAs)
Time frame: Approximately 85 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Astegolimab in people with Healthy Volunteers, run by Genentech, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve from Hour 0 to the time of last measurable concentration (AUC0-t) of astegolimab (time frame: Approximately 85 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.