Kidney DiseasesPhase 1NCT04880291
First-In-Human Study of GFB-024 in Healthy Overweight and Obese Participants, and Participants With Type 2 Diabetes
A Phase 1 study testing GFB-024 in people with Kidney Diseases and Diabetic Nephropathies, run by Goldfinch Bio, Inc. at 1 site in United States.
Trial summary
GFB-024 is intended for use in patients with kidney disease such as diabetic nephropathy. This study is the first time GFB-024 has been used in humans. The first part of the study will assess the safety of a single dose of GFB-024 in healthy overweight and obese volunteers and the effect of GFB-024 on the body as… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Diseases, Diabetic Nephropathies, Diabetes Complications
- What is being tested?
- GFB-024
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2021to 8 Feb 2022
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 75 years of age at the time of signing informed consent.
- Body mass index (BMI) between 25.0 and 40.0 kg/m2, inclusive, at Screening.
- Female participants will be of non-childbearing potential.
- Male participants will agree to use contraception while on study intervention and for at least 6 months after the last dose of study intervention.
- SAD cohorts only: Participants must be in good health.
- Repeat-dose cohort only: Type 2 diabetes mellitus (T2DM) treated with lifestyle modification or metformin, and in otherwise good health except for well-controlled common conditions associated with T2DM, such as hypertension and dyslipidemia.
Who cannot join
- History of, or treatment for, psychiatric illness, including anxiety or depression within 5 years of the Screening visit.
- Participants with a history of attempted suicide or clinically significant suicidal ideation.
- History of cardiovascular disease.
- Blood pressure >155 mmHg systolic or >95 mmHg diastolic.
- History of alcoholism or drug/chemical abuse within 2 years prior to Screening.
- Alcohol consumption of >21 units per week for males and >14 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1.5 oz (45 mL) liquor, or 5 oz (150 mL) wine.
Show all 9Show fewer
- History of significant hypersensitivity, intolerance, or allergy to more than one class of drugs.
- Positive hepatitis panel and/or positive human immunodeficiency virus test. Participants whose results are compatible with prior immunization may be included.
- SAD cohorts only: Fasting glucose >126 mg/dL.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-In-Human, Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GFB-024 as a Single Dose in Healthy Overweight and Obese Participants and as Multiple Doses in Participants With Type 2 Diabetes Mellitus
GFB-024 is intended for use in patients with kidney disease such as diabetic nephropathy. This study is the first time GFB-024 has been used in humans. The first part of the study will assess the safety of a single dose of GFB-024 in healthy overweight and obese volunteers and the effect of GFB-024 on the body as compared to an inactive placebo medication. The second part of the study will assess the safety of repeated doses of GFB-024 in participants with Type 2 diabetes and the effect of GFB-024 on the body as compared to an inactive placebo medication.
Read the detailed description
This is a first-in-human study. It is intended to provide the initial safety, pharmacokinetics (PK), and pharmacology data for GFB-024 in humans. This study will comprise a single ascending dose (SAD) escalation component in healthy overweight and obese volunteer participants and a repeat-dose component to confirm repeat-dose safety, tolerability, PK, and immunogenicity in participants with Type 2 diabetes mellitus. It will also explore potential cannabinoid-1 receptor (CB1) activity, participant selection, pharmacodynamics, and differential response biomarkers.
- Conditions
- Kidney Diseases, Diabetic Nephropathies, Diabetes Complications, Diabetes Mellitus, Endocrine System Diseases
- Being tested
- GFB-024, Placebo
- Medical subject headings
- Kidney Diseases, Diabetic Nephropathies, Diabetes Complications, Diabetes Mellitus, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GFB-024Drug
Peripherally acting Cannabinoid-1 receptor inverse agonist monoclonal antibody
PlaceboDrug
Matched placebo
| Study group | Role | What they receive |
|---|---|---|
| GFB-024 SAD Active | Active comparator | Single ascending dose arm of GFB-024 treatment Receives: Drug: GFB-024 |
| SAD Placebo | Placebo comparator | Single ascending dose arm of placebo treatment Receives: Drug: Placebo |
| GFB-024 Repeat-dose Active | Active comparator | Repeat-dose arm of GFB-024 treatment Receives: Drug: GFB-024 |
| Repeat-dose Placebo | Placebo comparator | Repeat-dose arm of placebo treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability following single ascending doses of GFB-024
Number of participants with serious and other nonserious adverse events
Measured: Approximately 10 weeks
Secondary outcomes (7)
Safety and tolerability following repeated doses over 4 weeks of GFB-024
Number of participants with serious and other nonserious adverse events
Measured: Approximately 13 weeks
Characterize PK of GFB-024 following single ascending doses (Cmax)
Maximum serum concentration
Measured: Approximately 10 weeks
Characterize PK of GFB-024 following single ascending doses (AUClast)
Area under the serum concentration-time curve from time zero to last measurable concentration
Measured: Approximately 10 weeks
Characterize PK of GFB-024 following repeated doses (Cmax)
Maximum serum concentration
Measured: Approximately 13 weeks
Characterize PK of GFB-024 following repeated doses (AUClast)
Area under the serum concentration-time curve from time zero to last measurable concentration
Measured: Approximately 13 weeks
Characterize the incidence and persistence of immunogenicity of GFB-024 following single ascending doses
Number of participants with confirmed antidrug antibodies
Measured: Approximately 10 weeks
Characterize the incidence and persistence of immunogenicity of GFB-024 following repeated doses
Number of participants with confirmed antidrug antibodies
Measured: Approximately 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start5 May 2021
- Primary completion8 Feb 2022
- Study completion8 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goldfinch Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ingela Danielsson, MD, PhD, MBA, Principal investigator, Worldwide Clinical Trails
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880291
- Sponsor's protocol ID
- GFB-024-102
- Status last verified
- Mar 2022
- First submitted
- 5 May 2021
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- 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 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-In-Human, Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GFB-024 as a Single Dose in Healthy Overweight and Obese Participants and as Multiple Doses in Participants With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04880291
- Acronym / sponsor ID
- GFB-024-102
- Conditions
- Kidney Diseases, Diabetic Nephropathies, Diabetes Complications, Diabetes Mellitus, Endocrine System Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Goldfinch Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 May 2021 (actual)
- Primary completion
- 8 Feb 2022 (actual)
- Study completion
- 8 Feb 2022 (actual)
- First posted
- 10 May 2021 (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.
GFB-024 is intended for use in patients with kidney disease such as diabetic nephropathy. This study is the first time GFB-024 has been used in humans. The first part of the study will assess the safety of a single dose of GFB-024 in healthy overweight and obese volunteers and the effect of GFB-024 on the body as compared to an inactive placebo medication. The second part of the study will assess the safety of repeated doses of GFB-024 in participants with Type 2 diabetes and the effect of GFB-024 on the body as compared to an inactive placebo medication.
Detailed description
This is a first-in-human study. It is intended to provide the initial safety, pharmacokinetics (PK), and pharmacology data for GFB-024 in humans. This study will comprise a single ascending dose (SAD) escalation component in healthy overweight and obese volunteer participants and a repeat-dose component to confirm repeat-dose safety, tolerability, PK, and immunogenicity in participants with Type 2 diabetes mellitus. It will also explore potential cannabinoid-1 receptor (CB1) activity, participant selection, pharmacodynamics, and differential response biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GFB-024 SAD Active | Active comparator | Drug: GFB-024Single ascending dose arm of GFB-024 treatment |
| SAD Placebo | Placebo comparator | Drug: PlaceboSingle ascending dose arm of placebo treatment |
| GFB-024 Repeat-dose Active | Active comparator | Drug: GFB-024Repeat-dose arm of GFB-024 treatment |
| Repeat-dose Placebo | Placebo comparator | Drug: PlaceboRepeat-dose arm of placebo treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 to 75 years of age at the time of signing informed consent.
- Body mass index (BMI) between 25.0 and 40.0 kg/m2, inclusive, at Screening.
- Female participants will be of non-childbearing potential.
- Male participants will agree to use contraception while on study intervention and for at least 6 months after the last dose of study intervention.
- SAD cohorts only: Participants must be in good health.
Key exclusion criteria (9 listed)
- History of, or treatment for, psychiatric illness, including anxiety or depression within 5 years of the Screening visit.
- Participants with a history of attempted suicide or clinically significant suicidal ideation.
- History of cardiovascular disease.
- Blood pressure >155 mmHg systolic or >95 mmHg diastolic.
- History of alcoholism or drug/chemical abuse within 2 years prior to Screening.
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 |
|---|---|---|
| GFB-024Peripherally acting Cannabinoid-1 receptor inverse agonist monoclonal antibody | Drug | GFB-024 Repeat-dose Active, GFB-024 SAD Active |
| PlaceboMatched placebo | Drug | Repeat-dose Placebo, SAD Placebo |
Primary outcome
Safety and tolerability following single ascending doses of GFB-024
Time frame: Approximately 10 weeks
Number of participants with serious and other nonserious adverse events
7 secondary outcomes
Safety and tolerability following repeated doses over 4 weeks of GFB-024
Time frame: Approximately 13 weeks
Characterize PK of GFB-024 following single ascending doses (Cmax)
Time frame: Approximately 10 weeks
Characterize PK of GFB-024 following single ascending doses (AUClast)
Time frame: Approximately 10 weeks
Characterize PK of GFB-024 following repeated doses (Cmax)
Time frame: Approximately 13 weeks
Characterize PK of GFB-024 following repeated doses (AUClast)
Time frame: Approximately 13 weeks
Characterize the incidence and persistence of immunogenicity of GFB-024 following single ascending doses
Time frame: Approximately 10 weeks
Characterize the incidence and persistence of immunogenicity of GFB-024 following repeated doses
Time frame: Approximately 13 weeks
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 28 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Kidney Diseases
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
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.
Ingela Danielsson, MD, PhD, MBA principal investigator
Worldwide Clinical Trails
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 GFB-024 in people with Kidney Diseases and Diabetic Nephropathies, run by Goldfinch Bio, Inc. at 1 site 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 6 inclusion and 9 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 28 Mar 2022. 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 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. 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?
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?
Safety and tolerability following single ascending doses of GFB-024 (time frame: Approximately 10 weeks). 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 28 Mar 2022.