Atopic Dermatitis (AD)Phase 1NCT06920693
Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GB-7624 in Healthy Adult Participants
A Phase 1 study testing GB-7624 in people with Atopic Dermatitis (AD), run by Generate Biomedicines at 1 site in Australia.
Trial summary
This is a randomised, double-blinded, placebo-controlled first in human (FIH) trial to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity of GB-7624. The trial will have two parts: a SAD component and a MAD component. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- GB-7624
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 27 Mar 2025to 30 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must have given written informed consent before any trial-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
- Adults, 18 to 65 years of age (inclusive) at the screening visit.
- Body mass index (BMI) greater than or equal to 18.0 and less than or equal to 32.0 kg/m2 (inclusive)
- Medically healthy as determined by medical history, vital signs, physical examination (no CS findings),ECG and clinical laboratory tests at screening and pre-dose on Day -1 or Day 1. This includes the following:
- Systolic blood pressure (BP) in the range of 90 to 140 mmHg (inclusive) and diastolic BP in the range of4050 to 90 mmHg (inclusive) after 5 minutes in seated, semi-recumbent, or supine position
- Heart rate (HR) in the range of 40 to 100 bpm (inclusive) after 5 minutes rest in seated, semi-recumbent, or supine position
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- Body temperature, between 35.5°C and 37.5°C (inclusive)
- Electrocardiogram (ECG) without CS abnormalities including QT interval corrected for Fredericia (QTcF) <450 msec for male participants and <470 msec for female participants.
- In the opinion of the investigator, no significant findings in serum chemistry, haematology, coagulation and urinalysis tests.
- Female volunteers must:
- Be of non-child-bearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 months before the screening visit or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle-stimulating hormone (FSH) level consistent with postmenopausal status, per local laboratory guidelines), or
- A woman of childbearing potential (WOCBP) must have a negative pregnancy test at Screening (blood test) and before the first trial drug administration (Day -1 urine test). They must agree not to attempt to become pregnant or donate ova and to use protocol-defined methods of contraception from one month prior to screening until at least 360 days after the last dose of study drug.
- Women who are currently lactating, breastfeeding, receiving hormone therapy with the intention of having children, planning to donate ova or planning to become pregnant during the trial and within 360days after last dose of trial drug, are excluded from participation.
- Male participants (including vasectomised males and those with documented azoospermia): must agree to not donate sperm and, if engaging in sexual intercourse with a WOCBP, must agree to use a condom in addition to using use protocol-defined methods of contraception and agree to refrain from donating sperm from screening through at least 360 days after the last dose of trial drug. If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, agree to use a condom from signing the consent form until at least 360 days after the last dose of study drug.
- Have suitable venous access for blood sampling.
- Be willing and able to comply with all trial assessments and adhere to the protocol schedule and restrictions
Who cannot join
- History or presence of significant cardiovascular, pulmonary (excluding resolved childhood asthma, at the discretion of the PI or delegate), hepatic, renal, haematological, neoplastic, gastrointestinal, endocrine, immunologic, dermatologic, neurological (excluding migraine, at the discretion of the PI or delegate),ocular or psychiatric disease (excluding non-hospitalised depression and anxiety, at the discretion of the PI or delegate), including any acute illness or surgery within the past 3 months determined by the PI (in consultation with the MM/SMR) to be clinically relevant. Participants with a history of malignant disease in the last 5 years (excludes localised, non-melanoma skin cancers treated with curative intent and not on active therapy).
- Current infection or acute illness or fever within 3 days before trial enrolment (enrolment may be delayed for full recovery if acceptable to the investigator), that requires antibiotic, antifungal or antiviral medications.
- Diagnosed active helminth infection or travel in last 3 months to areas at high risk of these infections.
- Positive testing for human immunodeficiency virus (HIV)-1 and 2, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit.
- Current smokers or ex-smokers who have given up smoking for less than or equal to 3 months. Social/casual smokers (defined as <5 cigarettes per week) may be included if willing to completely abstain from smoking from screening through the duration of the trial.
- Positive cotinine testing at Day -1.
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- Presence or history of substance abuse, alcohol abuse or excessive intake of alcohol within 2 years prior to screening (refer to exclusion criterion 9 and 10).
- Positive coronavirus disease 2019 (COVID-19) test on Day -1.
- Positive drug or alcohol testing at screening and/or Day -1.
- Regular consumption of more than 10 standard alcoholic drinks/week and/or more than 4 standard alcoholic drinks on any one day, where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9% Alc/Vol], 100 mL wine [12% Alc/Vol], or 30 mL spirit [40% Alc/Vol]).
- History of any severe allergic reactions (necessitating hospitalisation, oxygen and/or epinephrine use),which in the opinion of the PI (or delegate), would interfere with the volunteer's ability to participate in the study.
- Use of any prescription within 14 days prior to admission to the study site (Day -1) and/or non-prescription, over-the-counter (OTC) medication (including dietary or herbal supplements) within 7 days or 5 half-lives of the medication (whichever is longer) prior to admission to the study site (Day -1), except use of contraceptives or hormone replacement therapy and the use of paracetamol (up to 2 g per day).Vitamins may be permitted in discussion with the Sponsor.
- History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death) or a known arrythmia.
- Liver function test results elevated >1.5-fold above the upper limit of normal (ULN) for bilirubin (total, conjugated and unconjugated), alkaline phosphatase (ALP), aspartate aminotransferase (AST) or alanine aminotransferase (ALT).
- Estimated creatinine clearance (CrCl) < 60 mL/min using the Cockcroft-Gault formula or serum creatinine >1.5-fold above the ULN.
- History of sensitivity to any of the trial medications, or its components, or a history of drug reaction or other allergies that, in the opinion of the PI or MM, contradict their participation.
- Note: This includes any previous allergic reaction to biologic agents.
- Presence or evidence of recent sunburn, scar tissue, tattoos, open sores, or dermatological conditions, that in the opinion of the PI (or delegate) would interfere with the intended SC injection site or evaluation of the participant's response to the study drug and ability to assess for any injection site reactions.
- Receipt of any live attenuated vaccinations within 30 days prior to admission to the study site (Day -1)and non-live vaccines within 14 days prior to admission to the study site (Day -1).
- Note: Influenza, COVID-19 and pneumococcal vaccines permitted up to 7 days prior to admission to the study site (Day -1).
- Donation of whole blood within 30 days prior to admission to the study site (Day -1), or loss of whole blood of more than 500 mL within 30 days prior to admission to the study site (Day -1). Receipt of a bloodtransfusion within 1 year of the admission to the study site (Day -1).
- Donation of plasma within 1 week prior to screening visit.
- Receipt of any biological drugs such as monoclonal antibodies, immunoglobulin or other bloodproducts within 3 months or 5 half-lives (whichever is longer) of admission to the study site (Day -1).
- Participation in another investigational clinical trial with the EOS visit for the trial within 30 days prior toadmission to the study site (Day -1) or within 5 half-lives of the previous investigational drug (whichever islonger).
- Any other condition or prior therapy, which, in the opinion of the PI, would make the participant unsuitable for this trial, including unable to cooperate fully with the requirements of the trial protocol or likely to be non-compliant with any trial requirements.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Generate Biomedicines Clinical Site
Herston, Queensland, 4007
About this study
Official title: A Phase 1, First in Human, Randomised, Double-Blind, Placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Investigate the Safety, Tolerability and Pharmacokinetics of GB-7624 Administered Subcutaneously in Healthy Adult Participants
This is a randomised, double-blinded, placebo-controlled first in human (FIH) trial to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity of GB-7624. The trial will have two parts: a SAD component and a MAD component.
Part A (SAD): a total of 24 healthy volunteers are planned to be enrolled across 3 SAD cohorts and will involve the administration of a single subcutaneous (SC) dose of GB-7624 (300 mg, 600 mg, or 1200 mg) or placebo on Day 1 in cohorts A1, A2, and A3.
Read more
Part B (MAD): a total of 16 healthy volunteers are planned to be enrolled across 2 MAD cohorts and will involve the administration of multiple SC doses of GB-7624 (300 mg on Day 1 and Day 15 or 600 mg on Day1 and Day 15) or placebo in cohorts B1 and B2.
The decision to escalate between dose levels in the SAD (Part A) and the MAD (Part B) as well as the decision to proceed from Part A to Part B will be based on safety review committee (SRC) review of prior cohorts, blinded available safety, tolerability and PK data.
Study drug will be administered at the study site by trained study site personnel to ensure compliance. The administration of all trial intervention will be recorded in eCRF. Compliance will be assured by direct supervision and witnessing of trial intervention administration.
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- GB-7624, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB-7624Drug
Study Drug GB-7624
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Study intervention: GB-7624 | Experimental | Not described Receives: Drug: GB-7624 |
| Study Intervention: Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Outcome: To assess the safety and tolerability of single doses of GB-7624 administered subcutaneously (SC) in healthy volunteers.
Participant incidence and severity of treatment-emergent adverse events (TEAEs), serious AEs (SAEs),and TEAEs leading to discontinuation of study treatment.
Clinically significant (CS) changes from baseline in:
- Clinical laboratory results (haematology, clinical chemistry, coagulation and urinalysis)
- Vital signs
- Twelve-lead electrocardiograms (ECGs)
Measured: Day -1 to Day 360
Composite Outcome: To assess the safety and tolerability of multiple doses of GB-7624 administered SC in healthy volunteers
Participant incidence and severity of treatment-emergent AEs (TEAEs), serious AEs (SAEs), and TEAEs leading to discontinuation of study treatment.
Clinically significant (CS) changes from baseline in:
- Clinical laboratory results (haematology, clinical chemistry, coagulation and urinalysis)
- Vital signs
- Twelve-lead electrocardiograms (ECGs)
Measured: Day -1 to Day 360
Secondary outcomes (16)
To characterise the maximum concentration (Cmax) of GB-7624 following single doses of GB-7624 administered SC in healthy volunteers
The Cmax of GB-7624 following single SC doses in healthy volunteers will be analyzed
Measured: Day 1 to Day 360
To characterise the time to peak drug concentration (Tmax) of GB-7624 following single doses of GB-7624 administered SC in healthy volunteers
The Tmax of GB-7624 following single SC doses in healthy volunteers will be analyzed
Measured: Day 1 to Day 360
To characterise the half-life (t1/2) of GB-7624 following single doses of GB-7624 administered SC in healthy volunteers
The t1/2 of GB-7624 following single SC doses in healthy volunteers will be analyzed
Measured: Day 1 to Day 360
To characterise the the area under the curve to last quantifiable timepoint (AUClast) of GB-7624 following single doses of GB-7624 administered SC in healthy volunteers
The AUClast of GB-7624 following single SC doses in healthy volunteers will be analyzed
Measured: Day 1 to Day 360
To characterise the volume of distribution (V/F) of GB-7624 following single doses of GB-7624 administered SC in healthy volunteers
The V/F of GB-7624 following single SC doses in healthy volunteers will be analyzed
Measured: Day 1 to Day 360
To characterise the the area under the plasma concentration-time curve (AUC) of GB-7624 following single doses of GB-7624 administered SC in healthy volunteers
The AUC of GB-7624 following single SC doses in healthy volunteers will be analyzed
Measured: Day 1 to Day 360
To characterise the the area under the plasma concentration-time curve from time zero to infinity (AUCinf) of GB-7624 following single doses of GB-7624 administered SC in healthy volunteers
The AUCinf of GB-7624 following single SC doses in healthy volunteers will be analyzed
Measured: Day 1 to Day 360
To characterise the total body clearance from plasma (CL/F) of GB-7624 following singles dose of GB-7624 administered SC in healthy volunteers
The CL/F of GB-7624 following single SC doses in healthy volunteers will be analyzed
Measured: Day 1 to Day 360
To characterise the maximum concentration (Cmax) of GB-7624 following multiple doses of GB-7624 administered SC in healthy volunteers
The Cmax of GB-7624 following multiple SC doses in healthy volunteers will be analyzed
Measured: Day 1 to Day 360
To characterise the time to peak drug concentration (Tmax) of GB-7624 following multiple doses of GB-7624 administered SC in healthy volunteers
The Tmax of GB-7624 following multiple SC doses in healthy volunteers will be analyzed
Measured: Day 1 to Day 360
To characterise the half-life (t1/2) of GB-7624 following multiple doses of GB-7624 administered SC in healthy volunteers
The t1/2 of GB-7624 following multiple SC doses in healthy volunteers will be analyzed
Measured: Day 1 to Day 360
To characterise the the area under the curve to last quantifiable timepoint (AUClast) of GB-7624 following multiple doses of GB-7624 administered SC in healthy volunteers
The AUClast of GB-7624 following multiple SC doses in healthy volunteers will be analyzed
Measured: Day 1 to Day 360
To characterise the volume of distribution (V/F) of GB-7624 following a multiple dose of GB-7624 administered SC in healthy volunteers
The V/F of GB-7624 following multiple SC doses in healthy volunteers will be analyzed
Measured: Day 1 to Day 360
To characterise the the area under the plasma concentration-time curve (AUC) of GB-7624 following multiple doses of GB-7624 administered SC in healthy volunteers
The AUC of GB-7624 following multiple SC doses in healthy volunteers will be analyzed
Measured: Day 1 to Day 360
To characterise the the area under the plasma concentration-time curve from time zero to infinity (AUCinf) of GB-7624 following multiple doses of GB-7624 administered SC in healthy volunteers
The AUCinf of GB-7624 following multiple SC doses in healthy volunteers will be analyzed
Measured: Day 1 to Day 360
To characterise the total body clearance from plasma (CL/F) of GB-7624 following multiple doses of GB-7624 administered SC in healthy volunteers
The CL/F of GB-7624 following multiple SC doses in healthy volunteers will be analyzed
Measured: Day 1 to Day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start27 Mar 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Generate Biomedicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920693
- Sponsor's protocol ID
- GB-7624-101
- Status last verified
- Dec 2025
- First submitted
- 11 Mar 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First in Human, Randomised, Double-Blind, Placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Investigate the Safety, Tolerability and Pharmacokinetics of GB-7624 Administered Subcutaneously in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06920693
- Acronym / sponsor ID
- GB-7624-101
- Conditions
- Atopic Dermatitis (AD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Generate BiomedicinesIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 10 Apr 2025 (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.
This is a randomised, double-blinded, placebo-controlled first in human (FIH) trial to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity of GB-7624. The trial will have two parts: a SAD component and a MAD component.
Part A (SAD): a total of 24 healthy volunteers are planned to be enrolled across 3 SAD cohorts and will involve the administration of a single subcutaneous (SC) dose of GB-7624 (300 mg, 600 mg, or 1200 mg) or placebo on Day 1 in cohorts A1, A2, and A3.
Part B (MAD): a total of 16 healthy volunteers are planned to be enrolled across 2 MAD cohorts and will involve the administration of multiple SC doses of GB-7624 (300 mg on Day 1 and Day 15 or 600 mg on Day1 and Day 15) or placebo in cohorts B1 and B2.
The decision to escalate between dose levels in the SAD (Part A) and the MAD (Part B) as well as the decision to proceed from Part A to Part B will be based on safety review committee (SRC) review of prior cohorts, blinded available safety, tolerability and PK data.
Study drug will be administered at the study site by trained study site personnel to ensure compliance. The administration of all trial intervention will be recorded in eCRF. Compliance will be assured by direct supervision and witnessing of trial intervention administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study intervention: GB-7624 | Experimental | Drug: GB-7624 |
| Study Intervention: Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Participants must have given written informed consent before any trial-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
- Adults, 18 to 65 years of age (inclusive) at the screening visit.
- Body mass index (BMI) greater than or equal to 18.0 and less than or equal to 32.0 kg/m2 (inclusive)
- Medically healthy as determined by medical history, vital signs, physical examination (no CS findings),ECG and clinical laboratory tests at screening and pre-dose on Day -1 or Day 1. This includes the following:
- Female volunteers must:
Key exclusion criteria (25 listed)
- History or presence of significant cardiovascular, pulmonary (excluding resolved childhood asthma, at the discretion of the PI or delegate), hepatic, renal, haematological, neoplastic, gastrointestinal, endocrine, immunologic, dermatologic, neurological (excluding migraine, at the discretion of the PI or delegate),ocular or psychiatric disease (excluding non-hospitalised depression and anxiety, at the discretion of the PI or delegate), including any acute illness or surgery within the past 3 months determined by the PI (in consultation with the MM/SMR) to be clinically relevant. Participants with a history of malignant disease in the last 5 years (excludes localised, non-melanoma skin cancers treated with curative intent and not on active therapy).
- Current infection or acute illness or fever within 3 days before trial enrolment (enrolment may be delayed for full recovery if acceptable to the investigator), that requires antibiotic, antifungal or antiviral medications.
- Diagnosed active helminth infection or travel in last 3 months to areas at high risk of these infections.
- Positive testing for human immunodeficiency virus (HIV)-1 and 2, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit.
- Current smokers or ex-smokers who have given up smoking for less than or equal to 3 months. Social/casual smokers (defined as <5 cigarettes per week) may be included if willing to completely abstain from smoking from screening through the duration of the trial.
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 |
|---|---|---|
| GB-7624Study Drug GB-7624 | Drug | Study intervention: GB-7624 |
| PlaceboPlacebo | Drug | Study Intervention: Placebo |
Primary outcome
Composite Outcome: To assess the safety and tolerability of single doses of GB-7624 administered subcutaneously (SC) in healthy volunteers.
Time frame: Day -1 to Day 360
Participant incidence and severity of treatment-emergent adverse events (TEAEs), serious AEs (SAEs),and TEAEs leading to discontinuation of study treatment. Clinically significant (CS) changes from baseline in: * Clinical laboratory results (haematology, clinical chemistry, coagulation and urinalysis) * Vital signs * Twelve-lead electrocardiograms (ECGs)
Composite Outcome: To assess the safety and tolerability of multiple doses of GB-7624 administered SC in healthy volunteers
Time frame: Day -1 to Day 360
Participant incidence and severity of treatment-emergent AEs (TEAEs), serious AEs (SAEs), and TEAEs leading to discontinuation of study treatment. Clinically significant (CS) changes from baseline in: * Clinical laboratory results (haematology, clinical chemistry, coagulation and urinalysis) * Vital signs * Twelve-lead electrocardiograms (ECGs)
16 secondary outcomes
To characterise the maximum concentration (Cmax) of GB-7624 following single doses of GB-7624 administered SC in healthy volunteers
Time frame: Day 1 to Day 360
To characterise the time to peak drug concentration (Tmax) of GB-7624 following single doses of GB-7624 administered SC in healthy volunteers
Time frame: Day 1 to Day 360
To characterise the half-life (t1/2) of GB-7624 following single doses of GB-7624 administered SC in healthy volunteers
Time frame: Day 1 to Day 360
To characterise the the area under the curve to last quantifiable timepoint (AUClast) of GB-7624 following single doses of GB-7624 administered SC in healthy volunteers
Time frame: Day 1 to Day 360
To characterise the volume of distribution (V/F) of GB-7624 following single doses of GB-7624 administered SC in healthy volunteers
Time frame: Day 1 to Day 360
To characterise the the area under the plasma concentration-time curve (AUC) of GB-7624 following single doses of GB-7624 administered SC in healthy volunteers
Time frame: Day 1 to Day 360
To characterise the the area under the plasma concentration-time curve from time zero to infinity (AUCinf) of GB-7624 following single doses of GB-7624 administered SC in healthy volunteers
Time frame: Day 1 to Day 360
To characterise the total body clearance from plasma (CL/F) of GB-7624 following singles dose of GB-7624 administered SC in healthy volunteers
Time frame: Day 1 to Day 360
To characterise the maximum concentration (Cmax) of GB-7624 following multiple doses of GB-7624 administered SC in healthy volunteers
Time frame: Day 1 to Day 360
To characterise the time to peak drug concentration (Tmax) of GB-7624 following multiple doses of GB-7624 administered SC in healthy volunteers
Time frame: Day 1 to Day 360
To characterise the half-life (t1/2) of GB-7624 following multiple doses of GB-7624 administered SC in healthy volunteers
Time frame: Day 1 to Day 360
To characterise the the area under the curve to last quantifiable timepoint (AUClast) of GB-7624 following multiple doses of GB-7624 administered SC in healthy volunteers
Time frame: Day 1 to Day 360
To characterise the volume of distribution (V/F) of GB-7624 following a multiple dose of GB-7624 administered SC in healthy volunteers
Time frame: Day 1 to Day 360
To characterise the the area under the plasma concentration-time curve (AUC) of GB-7624 following multiple doses of GB-7624 administered SC in healthy volunteers
Time frame: Day 1 to Day 360
To characterise the the area under the plasma concentration-time curve from time zero to infinity (AUCinf) of GB-7624 following multiple doses of GB-7624 administered SC in healthy volunteers
Time frame: Day 1 to Day 360
To characterise the total body clearance from plasma (CL/F) of GB-7624 following multiple doses of GB-7624 administered SC in healthy volunteers
Time frame: Day 1 to Day 360
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GB-7624 in people with Atopic Dermatitis (AD), run by Generate Biomedicines at 1 site in Australia.
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 16 inclusion and 25 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: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Composite Outcome: To assess the safety and tolerability of single doses of GB-7624 administered subcutaneously (SC) in healthy volunteers. (time frame: Day -1 to Day 360). The study lists 2 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 5 Dec 2025.