NCT03970122

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started May 2019

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

May 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2020

Completed
Last Updated

June 2, 2020

Status Verified

June 1, 2020

Enrollment Period

9 months

First QC Date

May 24, 2019

Last Update Submit

June 1, 2020

Conditions

Healthy Volunteers

Keywords

Glomerulosclerosisproteinurianephrotic syndromenephrosisfocal segmental glomerulosclerosiskidney diseasesurologic diseasesglomerulonephritisnephritisdiabetic kidney diseasediabetic nephropathiesendocrine system diseasesdiabetes complications

Outcome Measures

Primary Outcomes (8)

  • Incidence and severity of AEs

    Safety and tolerability

    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

    Approximately 5.5 weeks

  • Plasma PK parameters: Cmax

    PK

    Approximately 5.5 weeks

  • Plasma PK parameters: Tmax

    PK

    Approximately 5.5 weeks

  • Plasma PK parameters: AUC

    PK

    Approximately 5.5 weeks

  • Urine PK parameters: Ae

    PK

    Approximately 5.5 weeks

  • Urine PK parameters: Fe

    PK

    Approximately 5.5 weeks

  • Urine PK parameters: CLR

    PK

    Approximately 5.5 weeks

Study Arms (2)

GFB-887 SAD active

EXPERIMENTAL

GFB-887 single dose active

Drug: GFB-887

GFB-887 SAD placebo

PLACEBO COMPARATOR

GFB-887 single dose placebo

Drug: Placebo

Interventions

GFB-887DRUG

IMP

GFB-887 SAD active
PlaceboDRUG

Matching

GFB-887 SAD placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMales, females of non-childbearing potential
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Unit Inc.

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

ProteinuriaNephrotic SyndromeNephrosisGlomerulosclerosis, Focal SegmentalKidney DiseasesUrologic DiseasesGlomerulonephritisNephritisDiabetic NephropathiesEndocrine System DiseasesDiabetes Complications

Condition Hierarchy (Ancestors)

Urination DisordersFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes Mellitus

Study Officials

  • Jeanelle Kam, MD

    Covance Clinical Research Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Blinded
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Dose escalation, parallel assignment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2019

First Posted

May 31, 2019

Study Start

May 29, 2019

Primary Completion

March 4, 2020

Study Completion

April 4, 2020

Last Updated

June 2, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)