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The Safety and Efficacy of FB2001 in Healthy Subjects and Patients With COVID-19 Infection

Primary Purpose

Covid19

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FB2001
FB2001 Placebo
Sponsored by
Frontier Biotechnologies Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring SARS-CoV-2

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects are required to meet ALL of the following criteria for enrollment into the Part 1 of the study:

  1. Male or female adults who are between 18 and 60 years old inclusive;
  2. Weigh at least 45kg, with a BMI of 19 to 30 kg/m2 inclusive;
  3. No serious underlying disease which would adversely affect the study conduct and data interpretation per the investigator;
  4. Female subjects should have negative results in serum pregnancy test at screening and negative urine pregnancy test at admission:

    1. Subjects of reproductive age and their partners agree to take 2 forms of effective contraceptive measures. Note: Using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives) [e.g., hormonal contraceptives (oral, patch, injectable or vaginal ring), implantable device (implantable rod or intrauterine device), or a double barrier (e.g., diaphragm, cervical cap, oral, patch or vaginal hormonal contraceptive, condom, spermicide, or sponge)]
    2. Surgically sterile, with documentation, for at least 3 months prior to screening by one of the following means:

      Bilateral tubal ligation, Bilateral salpingectomy (with or without oophorectomy), Surgical hysterectomy, Bilateral oophorectomy (with or without hysterectomy), Postmenopausal, defined as the following: Last menstrual period greater than 12 months prior to screening

    3. Postmenopausal status confirmed by serum follicle stimulating hormone (FSH) and estradiol levels at screening
  5. Agree to refrain from alcohol during the study;
  6. Subjects should have normal (or abnormal but not clinically significant) laboratory results per the PI's judgement including the complete blood count, biochemistry, coagulation indices and urinalysis;
  7. Subjects should have a normal (or abnormal but not clinically significant) ECG and chest X-ray at screening;
  8. Subjects should be willing to cooperate and able to participate in this study, comply with all protocol requirements, and sign an informed consent;
  9. Male subjects with female partners of childbearing potential must agree to use condoms for the duration of the study and until 12 weeks after completion of dosing with the study drug and must refrain from donating sperm for this same period;
  10. Current non-smokers and those who have not smoked within the last 6 months. This includes the use of cigarettes, e-cigarettes, and nicotine replacement products.

Exclusion Criteria:

Subjects are required to meet NONE of the following criteria for enrollment into the Part 1 of the study:

  1. HIV antibody positive;
  2. HbsAg positive;
  3. HCV antibody positive;
  4. History of tuberculosis or lung disease as reported by subject;
  5. As reported by the subject has severe cardiovascular disease, neurological disease, hematological disease, infectious disease, mental disorder, liver disease, gastrointestinal disease, lung disease, endocrine disease,immune disease or kidney disease, or has a history of the above diseases, or other symptoms known to interfere with the absorption, distribution, metabolism, or excretion of the medicine, or other conditions that the investigator believes will increase the risk of the subject and might interfere with the study conduct and results interpretation
  6. Female subjects who are pregnant, lactating or have pregnancy plans in the 3 months after their study completion;
  7. Subjects who participated in any other clinical study within 30 days prior to screening;
  8. Subjects with known allergic reactions to the study drug or its excipients;
  9. Use of any medication, including prescription or over the counter, vitamins, herbal and/or mineral supplements, dietary supplements (and/or grape fruit juice) within 14 days prior to the first treatment or during the trial, which in the opinion of the investigator may influence the trial results or the safety of the subjects:

    1. Poor venous access or issues with needle sticks, e.g., syncope
    2. Donated or lost >500 mL of blood in the previous 3 months
    3. A history of prescription drug abuse, illicit drug use within 9 months prior to screening
    4. A positive screen for alcohol or drugs of abuse at screening or admission
  10. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.

Sites / Locations

  • Frontage Clinical Services, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

A1 FB2001 or Placebo

A2 FB2001 or Placebo

A3 FB2001 or Placebo

A4 FB2001 or Placebo

A5 FB2001 or Placebo

A6 FB2001 or Placebo

A7 FB2001 or Placebo

B1 FB2001 or Placebo

B2 FB2001 or Placebo

A8 FB2001 or Placebo

B3 FB2001 or Placebo

Arm Description

single dose

single dose

single dose

single dose

single dose

single dose

single dose

Once daily for 5 days

Once daily for 5 days

single dose

Twice daily for 5 days

Outcomes

Primary Outcome Measures

The Maximum Tolerable Dose (MTD)
Determination of the Maximum Tolerable Dose (MTD) of FB2001 based on the occurrence of Dose Limiting Toxicities (DLTs).
Number of participants with treatment-related adverse events as assessed by CTCAE V4.0
Evaluation of the safety and tolerability of FB2001 after a single and multiple dose administrations in healthy volunteers.
Pharmacokinetic parameters(Cmax)
Estimate of steady state Cmax for multiple dose administration of FB2001.
Pharmacokinetic parameters(AUC0-τ)
Estimate of steady state AUC0-τ for multiple dose administration of FB2001.

Secondary Outcome Measures

Full Information

First Posted
February 4, 2021
Last Updated
November 24, 2022
Sponsor
Frontier Biotechnologies Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04766931
Brief Title
The Safety and Efficacy of FB2001 in Healthy Subjects and Patients With COVID-19 Infection
Official Title
A Two-part, Phase I/II, Multi-center, Double-Blind, Randomized, Vehicle-controlled Study of the Safety and Efficacy of FB2001 in Patients With Moderate to Severe Coronavirus Disease 2019 (COVID-19) Infection
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
August 12, 2022 (Actual)
Study Completion Date
August 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Frontier Biotechnologies Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is an adaptive, Phase I/II study in 2 parts: Part 1 is to evaluate the Maximum Tolerable Dose (MTD) , tolerance, safety and pharmacokinetics of FB2001 in healthy subjects; Part 2 is to evaluate the safety, pharmacokinetics and efficacy of FB2001 in patients with moderate to severe COVID-19 disease.
Detailed Description
In Part 1 of this study, all subjects, after signing the Informed Consent Form (ICF), will be assessed during the screening phase. Only those subjects who successfully complete the screening phase and meet the study eligibility criteria will proceed to receive study treatment at the assigned doses and will be followed up for 14 days (for SAD) and 28 days (for MAD) to assess post-treatment safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
SARS-CoV-2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A1 FB2001 or Placebo
Arm Type
Experimental
Arm Description
single dose
Arm Title
A2 FB2001 or Placebo
Arm Type
Experimental
Arm Description
single dose
Arm Title
A3 FB2001 or Placebo
Arm Type
Experimental
Arm Description
single dose
Arm Title
A4 FB2001 or Placebo
Arm Type
Experimental
Arm Description
single dose
Arm Title
A5 FB2001 or Placebo
Arm Type
Experimental
Arm Description
single dose
Arm Title
A6 FB2001 or Placebo
Arm Type
Experimental
Arm Description
single dose
Arm Title
A7 FB2001 or Placebo
Arm Type
Experimental
Arm Description
single dose
Arm Title
B1 FB2001 or Placebo
Arm Type
Experimental
Arm Description
Once daily for 5 days
Arm Title
B2 FB2001 or Placebo
Arm Type
Experimental
Arm Description
Once daily for 5 days
Arm Title
A8 FB2001 or Placebo
Arm Type
Experimental
Arm Description
single dose
Arm Title
B3 FB2001 or Placebo
Arm Type
Experimental
Arm Description
Twice daily for 5 days
Intervention Type
Drug
Intervention Name(s)
FB2001
Other Intervention Name(s)
DC402234
Intervention Description
Subjects will be administered with FB2001 by intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
FB2001 Placebo
Other Intervention Name(s)
Placebo
Intervention Description
Subjects will be administered with FB2001 placebo by intravenous (IV) infusion
Primary Outcome Measure Information:
Title
The Maximum Tolerable Dose (MTD)
Description
Determination of the Maximum Tolerable Dose (MTD) of FB2001 based on the occurrence of Dose Limiting Toxicities (DLTs).
Time Frame
0~5 days
Title
Number of participants with treatment-related adverse events as assessed by CTCAE V4.0
Description
Evaluation of the safety and tolerability of FB2001 after a single and multiple dose administrations in healthy volunteers.
Time Frame
0~28 days
Title
Pharmacokinetic parameters(Cmax)
Description
Estimate of steady state Cmax for multiple dose administration of FB2001.
Time Frame
0~5 days
Title
Pharmacokinetic parameters(AUC0-τ)
Description
Estimate of steady state AUC0-τ for multiple dose administration of FB2001.
Time Frame
0~5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects are required to meet ALL of the following criteria for enrollment into the Part 1 of the study: Male or female adults who are between 18 and 60 years old inclusive; Weigh at least 45kg, with a BMI of 19 to 30 kg/m2 inclusive; No serious underlying disease which would adversely affect the study conduct and data interpretation per the investigator; Female subjects should have negative results in serum pregnancy test at screening and negative urine pregnancy test at admission: Subjects of reproductive age and their partners agree to take 2 forms of effective contraceptive measures. Note: Using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives) [e.g., hormonal contraceptives (oral, patch, injectable or vaginal ring), implantable device (implantable rod or intrauterine device), or a double barrier (e.g., diaphragm, cervical cap, oral, patch or vaginal hormonal contraceptive, condom, spermicide, or sponge)] Surgically sterile, with documentation, for at least 3 months prior to screening by one of the following means: Bilateral tubal ligation, Bilateral salpingectomy (with or without oophorectomy), Surgical hysterectomy, Bilateral oophorectomy (with or without hysterectomy), Postmenopausal, defined as the following: Last menstrual period greater than 12 months prior to screening Postmenopausal status confirmed by serum follicle stimulating hormone (FSH) and estradiol levels at screening Agree to refrain from alcohol during the study; Subjects should have normal (or abnormal but not clinically significant) laboratory results per the PI's judgement including the complete blood count, biochemistry, coagulation indices and urinalysis; Subjects should have a normal (or abnormal but not clinically significant) ECG and chest X-ray at screening; Subjects should be willing to cooperate and able to participate in this study, comply with all protocol requirements, and sign an informed consent; Male subjects with female partners of childbearing potential must agree to use condoms for the duration of the study and until 12 weeks after completion of dosing with the study drug and must refrain from donating sperm for this same period; Current non-smokers and those who have not smoked within the last 6 months. This includes the use of cigarettes, e-cigarettes, and nicotine replacement products. Exclusion Criteria: Subjects are required to meet NONE of the following criteria for enrollment into the Part 1 of the study: HIV antibody positive; HbsAg positive; HCV antibody positive; History of tuberculosis or lung disease as reported by subject; As reported by the subject has severe cardiovascular disease, neurological disease, hematological disease, infectious disease, mental disorder, liver disease, gastrointestinal disease, lung disease, endocrine disease,immune disease or kidney disease, or has a history of the above diseases, or other symptoms known to interfere with the absorption, distribution, metabolism, or excretion of the medicine, or other conditions that the investigator believes will increase the risk of the subject and might interfere with the study conduct and results interpretation Female subjects who are pregnant, lactating or have pregnancy plans in the 3 months after their study completion; Subjects who participated in any other clinical study within 30 days prior to screening; Subjects with known allergic reactions to the study drug or its excipients; Use of any medication, including prescription or over the counter, vitamins, herbal and/or mineral supplements, dietary supplements (and/or grape fruit juice) within 14 days prior to the first treatment or during the trial, which in the opinion of the investigator may influence the trial results or the safety of the subjects: Poor venous access or issues with needle sticks, e.g., syncope Donated or lost >500 mL of blood in the previous 3 months A history of prescription drug abuse, illicit drug use within 9 months prior to screening A positive screen for alcohol or drugs of abuse at screening or admission Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheng Yao
Organizational Affiliation
Frontier Biotechnologies Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Frontage Clinical Services, Inc.
City
Secaucus
State/Province
New Jersey
ZIP/Postal Code
07094
Country
United States

12. IPD Sharing Statement

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The Safety and Efficacy of FB2001 in Healthy Subjects and Patients With COVID-19 Infection

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