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FIH Ph 1 Study of TRPC5 Channel Inhibitor GFB-887 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03970122
Recruitment Status : Recruiting
First Posted : May 31, 2019
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Goldfinch Bio, Inc.

Brief Summary:
The study will comprise primarily a single-ascending dose (SAD) escalation component.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: GFB-887 Drug: Placebo Phase 1

Detailed Description:
Double-blind, randomized, placebo-controlled, single-dose, sequential-group design in up to 7 cohorts of healthy participants.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Dose escalation, parallel assignment
Masking: Double (Participant, Investigator)
Masking Description: Blinded
Primary Purpose: Other
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
Actual Study Start Date : May 29, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : April 1, 2020


Arm Intervention/treatment
Experimental: GFB-887 SAD active
GFB-887 single dose active
Drug: GFB-887
IMP

Placebo Comparator: GFB-887 SAD placebo
GFB-887 single dose placebo
Drug: Placebo
Matching




Primary Outcome Measures :
  1. Incidence and severity of AEs [ Time Frame: Approximately 5.5 weeks ]
    Safety and tolerability

  2. 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

  3. Plasma PK parameters: Cmax [ Time Frame: Approximately 5.5 weeks ]
    PK

  4. Plasma PK parameters: Tmax [ Time Frame: Approximately 5.5 weeks ]
    PK

  5. Plasma PK parameters: AUC [ Time Frame: Approximately 5.5 weeks ]
    PK

  6. Urine PK parameters: Ae [ Time Frame: Approximately 5.5 weeks ]
    PK

  7. Urine PK parameters: Fe [ Time Frame: Approximately 5.5 weeks ]
    PK

  8. Urine PK parameters: CLR [ Time Frame: Approximately 5.5 weeks ]
    PK



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Males, females of non-childbearing potential
Accepts Healthy Volunteers:   Yes
Criteria

Healthy Participant Cohorts - Key Inclusion Criteria:

  1. Males or females, of any race, between 18 and 55 years of age, inclusive, at Screening.
  2. Body mass index between 18.0 and 32.0 kg/m^2, inclusive, at Screening.
  3. 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.
  4. Female participants will be post-menopausal or surgically sterile (as confirmed by medical history).
  5. Male participants will agree to use contraception while on study drug and for at least 90 days after the final follow-up visit.
  6. Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.
  7. Participants must be in good health.

Healthy Participant Cohorts - Key Exclusion Criteria:

  1. Females of childbearing potential.
  2. 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).
  3. History of alcoholism or drug/chemical abuse within 2 years prior to (first) Check-in.
  4. Use of tobacco or nicotine-containing products within 60 days prior to (first) dosing, or positive cotinine at Screening or Check-in.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03970122


Contacts
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Contact: Christian Lynam 617 766 3749 clynam@goldfinchbio.com
Contact: Liron Walsh, MD 917 553 9659 lwalsh@goldfinchbio.com

Locations
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United States, Texas
Covance Clinical Research Unit Inc. Recruiting
Dallas, Texas, United States, 75247
Principal Investigator: Jeanelle Kam, MD         
Sponsors and Collaborators
Goldfinch Bio, Inc.
Investigators
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Principal Investigator: Jeanelle Kam, MD Covance Clinical Research Unit

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Responsible Party: Goldfinch Bio, Inc.
ClinicalTrials.gov Identifier: NCT03970122     History of Changes
Other Study ID Numbers: GFB-887-101
8391348 ( Other Identifier: Covance )
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Goldfinch Bio, Inc.:
Glomerulosclerosis
proteinuria
nephrotic syndrome
nephrosis
focal segmental glomerulosclerosis
kidney diseases
urologic diseases
glomerulonephritis
nephritis
diabetic kidney disease
diabetic nephropathies
endocrine system diseases
diabetes complications