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Completed

NCT Number: NCT03970122

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

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

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Key information

Conditions

Healthy Volunteers Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulosclerosis, Focal Segmental Kidney Diseases Male Urogenital Diseases Nephritis Nephrosis Nephrotic Syndrome Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit Inc.

Dallas, Texas, 75247, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GFB-887

Drug

IMP

Placebo

Drug

Matching

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Goldfinch Bio, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 31, 2019
Registry last updated
Jun 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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