Healthy VolunteersPhase 1NCT03970122
FIH Ph 1 Study of TRPC5 Channel Inhibitor GFB-887 in Healthy Subjects
A Phase 1 study testing GFB-887 in people with Healthy Volunteers, run by Goldfinch Bio, Inc. at 1 site in United States.
Trial summary
The study will comprise primarily a single-ascending dose (SAD) escalation component. 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?
- GFB-887
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2019to 4 Apr 2020
- 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
Healthy Participant Cohorts - Key Inclusion Criteria:
- Males or females, of any race, between 18 and 55 years of age, inclusive, at Screening.
- Body mass index between 18.0 and 32.0 kg/m^2, inclusive, at Screening.
- Systolic blood pressure of between 90 and 140 mmHg, diastolic blood pressure between 60 and 90 mmHg, and heart rate between 40 and 100 bpm at Screening.
- Female participants will be post-menopausal or surgically sterile (as confirmed by medical history).
- Male participants will agree to use contraception while on study drug and for at least 90 days after the final follow-up visit.
- Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.
- Participants must be in good health.
Healthy Participant Cohorts - Key Exclusion Criteria:
- Females of childbearing potential.
- Significant history or clinically significant manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- History of alcoholism or drug/chemical abuse within 2 years prior to (first) Check-in.
- Use of tobacco or nicotine-containing products within 60 days prior to (first) dosing, or positive cotinine at Screening or Check-in.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit Inc.
Dallas, Texas, 75247
About this study
Official title: A First-In-Human, Phase 1, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GFB-887, a TRPC5 Channel Inhibitor, in Healthy Subjects
The study will comprise primarily a single-ascending dose (SAD) escalation component.
Read the detailed description
Double-blind, randomized, placebo-controlled, single-dose, sequential-group design in up to 7 cohorts of healthy participants.
- Conditions
- Healthy Volunteers
- Being tested
- GFB-887, Placebo
- Keywords
- Glomerulosclerosis, proteinuria, nephrotic syndrome, nephrosis, focal segmental glomerulosclerosis, kidney diseases, urologic diseases, glomerulonephritis, nephritis, diabetic kidney disease, diabetic nephropathies, endocrine system diseases, diabetes complications
- Medical subject headings
- Proteinuria, Nephrotic Syndrome, Nephrosis, Glomerulosclerosis, Focal Segmental, Kidney Diseases, Urologic Diseases, Glomerulonephritis, Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GFB-887Drug
IMP
PlaceboDrug
Matching
| Study group | Role | What they receive |
|---|---|---|
| GFB-887 SAD active | Experimental | GFB-887 single dose active Receives: Drug: GFB-887 |
| GFB-887 SAD placebo | Placebo comparator | GFB-887 single dose placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of AEs
Safety and tolerability
Measured: Approximately 5.5 weeks
Incidence of clinically significant changes in laboratory parameters, 12 lead ECG parameters, vital signs measurements, spirometry, and physical examinations
Safety and tolerability
Measured: Approximately 5.5 weeks
Plasma PK parameters: Cmax
PK
Measured: Approximately 5.5 weeks
Plasma PK parameters: Tmax
PK
Measured: Approximately 5.5 weeks
Plasma PK parameters: AUC
PK
Measured: Approximately 5.5 weeks
Urine PK parameters: Ae
PK
Measured: Approximately 5.5 weeks
Urine PK parameters: Fe
PK
Measured: Approximately 5.5 weeks
Urine PK parameters: CLR
PK
Measured: Approximately 5.5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start29 May 2019
- Primary completion4 Mar 2020
- Study completion4 Apr 2020
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dose escalation, parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goldfinch Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeanelle Kam, MD, Principal investigator, Covance Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970122
- Sponsor's protocol ID
- GFB-887-101
- Other IDs
- 8391348
- Status last verified
- Jun 2020
- First submitted
- 24 May 2019
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-In-Human, Phase 1, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GFB-887, a TRPC5 Channel Inhibitor, in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03970122
- Acronym / sponsor ID
- GFB-887-101
- Conditions
- Healthy Volunteers
- Keywords
- Glomerulosclerosis, proteinuria, nephrotic syndrome, nephrosis, focal segmental glomerulosclerosis, kidney diseases, urologic diseases, glomerulonephritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Goldfinch Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 May 2019 (actual)
- Primary completion
- 4 Mar 2020 (actual)
- Study completion
- 4 Apr 2020 (actual)
- First posted
- 31 May 2019 (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 study will comprise primarily a single-ascending dose (SAD) escalation component.
Detailed description
Double-blind, randomized, placebo-controlled, single-dose, sequential-group design in up to 7 cohorts of healthy participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Dose escalation, parallel assignment
| Arm | Type | Receives |
|---|---|---|
| GFB-887 SAD active | Experimental | Drug: GFB-887GFB-887 single dose active |
| GFB-887 SAD placebo | Placebo comparator | Drug: PlaceboGFB-887 single dose placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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-887IMP | Drug | GFB-887 SAD active |
| PlaceboMatching | Drug | GFB-887 SAD placebo |
Primary outcome
Incidence and severity of AEs
Time frame: Approximately 5.5 weeks
Safety and tolerability
Incidence of clinically significant changes in laboratory parameters, 12 lead ECG parameters, vital signs measurements, spirometry, and physical examinations
Time frame: Approximately 5.5 weeks
Safety and tolerability
Plasma PK parameters: Cmax
Time frame: Approximately 5.5 weeks
PK
Plasma PK parameters: Tmax
Time frame: Approximately 5.5 weeks
PK
Plasma PK parameters: AUC
Time frame: Approximately 5.5 weeks
PK
Urine PK parameters: Ae
Time frame: Approximately 5.5 weeks
PK
Urine PK parameters: Fe
Time frame: Approximately 5.5 weeks
PK
Urine PK parameters: CLR
Time frame: Approximately 5.5 weeks
PK
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 2 Jun 2020.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Jeanelle Kam, MD principal investigator
Covance Clinical Research Unit
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-887 in people with Healthy Volunteers, 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?
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 2 Jun 2020. 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?
Incidence and severity of AEs (time frame: Approximately 5.5 weeks). The study lists 8 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 2 Jun 2020.