Back to results

First-In-Human Study of GFB-024 in Healthy Overweight and Obese Participants, and Participants With Type 2 Diabetes

Primary Purpose

Kidney Diseases, Diabetic Nephropathies, Diabetes Complications

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

GFB-024

Placebo

About this trial

This is an interventional treatment trial for Kidney Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Sites / Locations

Worldwide Clinical Trials

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

GFB-024 SAD Active

SAD Placebo

GFB-024 Repeat-dose Active

Repeat-dose Placebo

Arm Description

Single ascending dose arm of GFB-024 treatment

Single ascending dose arm of placebo treatment

Repeat-dose arm of GFB-024 treatment

Repeat-dose arm of placebo treatment

Outcomes

Primary Outcome Measures

Safety and tolerability following single ascending doses of GFB-024

Number of participants with serious and other nonserious adverse events

Secondary Outcome Measures

Safety and tolerability following repeated doses over 4 weeks of GFB-024

Number of participants with serious and other nonserious adverse events

Characterize PK of GFB-024 following single ascending doses (Cmax)

Maximum serum concentration

Characterize PK of GFB-024 following single ascending doses (AUClast)

Area under the serum concentration-time curve from time zero to last measurable concentration

Characterize PK of GFB-024 following repeated doses (Cmax)

Maximum serum concentration

Characterize PK of GFB-024 following repeated doses (AUClast)

Area under the serum concentration-time curve from time zero to last measurable concentration

Characterize the incidence and persistence of immunogenicity of GFB-024 following single ascending doses

Number of participants with confirmed antidrug antibodies

Characterize the incidence and persistence of immunogenicity of GFB-024 following repeated doses

Number of participants with confirmed antidrug antibodies

Full Information

NCT ID

NCT04880291

First Posted

May 5, 2021

Last Updated

March 24, 2022

Sponsor

Goldfinch Bio, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04880291

Brief Title

First-In-Human Study of GFB-024 in Healthy Overweight and Obese Participants, and Participants With Type 2 Diabetes

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

May 5, 2021 (Actual)

Primary Completion Date

February 8, 2022 (Actual)

Study Completion Date

February 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Goldfinch Bio, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Diseases, Diabetic Nephropathies, Diabetes Complications, Diabetes Mellitus, Endocrine System Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GFB-024 SAD Active

Arm Type

Active Comparator

Arm Description

Single ascending dose arm of GFB-024 treatment

Arm Title

SAD Placebo

Arm Type

Placebo Comparator

Arm Description

Single ascending dose arm of placebo treatment

Arm Title

GFB-024 Repeat-dose Active

Arm Type

Active Comparator

Arm Description

Repeat-dose arm of GFB-024 treatment

Arm Title

Repeat-dose Placebo

Arm Type

Placebo Comparator

Arm Description

Repeat-dose arm of placebo treatment

Intervention Type

Drug

Intervention Name(s)

GFB-024

Intervention Description

Peripherally acting Cannabinoid-1 receptor inverse agonist monoclonal antibody

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matched placebo

Primary Outcome Measure Information:

Title

Safety and tolerability following single ascending doses of GFB-024

Description

Number of participants with serious and other nonserious adverse events

Time Frame

Approximately 10 weeks

Secondary Outcome Measure Information:

Title

Safety and tolerability following repeated doses over 4 weeks of GFB-024

Description

Number of participants with serious and other nonserious adverse events

Time Frame

Approximately 13 weeks

Title

Characterize PK of GFB-024 following single ascending doses (Cmax)

Description

Maximum serum concentration

Time Frame

Approximately 10 weeks

Title

Characterize PK of GFB-024 following single ascending doses (AUClast)

Description

Area under the serum concentration-time curve from time zero to last measurable concentration

Time Frame

Approximately 10 weeks

Title

Characterize PK of GFB-024 following repeated doses (Cmax)

Description

Maximum serum concentration

Time Frame

Approximately 13 weeks

Title

Characterize PK of GFB-024 following repeated doses (AUClast)

Description

Area under the serum concentration-time curve from time zero to last measurable concentration

Time Frame

Approximately 13 weeks

Title

Characterize the incidence and persistence of immunogenicity of GFB-024 following single ascending doses

Description

Number of participants with confirmed antidrug antibodies

Time Frame

Approximately 10 weeks

Title

Characterize the incidence and persistence of immunogenicity of GFB-024 following repeated doses

Description

Number of participants with confirmed antidrug antibodies

Time Frame

Approximately 13 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ingela Danielsson, MD, PhD, MBA

Organizational Affiliation

Worldwide Clinical Trails

Official's Role

Principal Investigator

Facility Information:

Facility Name

Worldwide Clinical Trials

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78217

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

First-In-Human Study of GFB-024 in Healthy Overweight and Obese Participants, and Participants With Type 2 Diabetes

We'll reach out to this number within 24 hrs