A Bridging Study of FB2001 in Healthy Subjects

NCT05197179 | Completed Phase 1

• 1 other identifier: FB2001-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In the first human clinical trial conducted in the United States, single and multiple dosing of FB2001 in multiple dose groups were partially completed，and FB2001 demonstrated good safety and tolerability. The bridge study of FB2001 will be conducted in China to evaluated the safety and PK of FB2001 in healthy Chinese population. This is a randomized, double-blind, placebo-controlled study of single and multiple dosing.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (3)

• Evaluation of the safety and tolerability of FB2001 after a single and multiple dose administrations in healthy subjects

  The safety and overall tolerability assessments will be evaluated based on: * Incidence of Treatment-Emergent Adverse Events (TEAEs) and Adverse reactions (ADR) * Incidence of grade 3 and 4 AEs/ADRs * Incidence of SAE * Incidence of drug-related serious adverse events

  Day1 - Day 29

• Pharmacokinetic parameter (AUC0-τ)

  Pharmacokinetic outcome measures: Estimate of steady state AUC0-τ for single and multiple dose administration of FB2001

  Day1 - Day 6

• Pharmacokinetic parameter (Cmax)

  Pharmacokinetic outcome measures: Estimate of steady state Cmax for single and multiple dose administration of FB2001

  Day1 - Day 6

Study Arms (5)

Single-dose A

OTHER

A single dose A of FB2001 or placebo will be administered by intravenous (IV) infusion

Drug: FB2001; Other: FB2001 placebo

Single-dose B

OTHER

A single dose B of FB2001 or placebo will be administered by intravenous (IV) infusion

Drug: FB2001; Other: FB2001 placebo

Multiple-dose A

OTHER

Dose A of FB2001 or placebo will be administered by intravenous (IV) infusion once daily for 5 consecutive days

Drug: FB2001; Other: FB2001 placebo

Multiple-dose B

OTHER

Dose B of FB2001 or placebo will be administered by intravenous (IV) infusion twice daily for 5.5 consecutive days

Drug: FB2001; Other: FB2001 placebo

Single-dose C

OTHER

A single dose C of FB2001 or placebo will be administered by intravenous (IV) infusion

Drug: FB2001; Other: FB2001 placebo

Interventions

FB2001 DRUG

Subjects will be administered with FB2001 by intravenous (IV) infusion

Also known as: DC402234

Multiple-dose A; Multiple-dose B; Single-dose A; Single-dose B; Single-dose C

FB2001 placebo OTHER

Subjects will be administered with FB2001 by intravenous (IV) infusion

Multiple-dose A; Multiple-dose B; Single-dose A; Single-dose B; Single-dose C

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Subjects should have normal (or abnormal but not clinically significant) laboratory results per the PI's judgement, including 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
• 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.
• Female subjects should have negative results in serum pregnancy test at screening and negative urine pregnancy test at screening.
• Agree to have no parenting plan during the study period and for 3 months after administration, and be able to use highly effective contraceptive measures, such as:
• Complete abstinence (e.g. as the preferred lifestyle)
• Intrauterine device (IUD)
• Female barrier method: cervical or uterine cap with spermicidal agent
• Tubal sterilization
• Vasectomy for male subjects or partners
• Hormone-containing contraceptives
• Levonorgestrel implant

You may not qualify if:

• HIV antibody positive;
• HBsAg positive;
• HCV antibody positive;
• Syphilis spirochetes antibody positive;
• History of tuberculosis or lung disease as reported by subject;
• Subject has severe cardiovascular disease, neurological disease, hematological disease, infectious disease, mental disorder, liver disease, gastrointestinal 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 interpretations;
• Female subjects who are pregnant, lactating or have pregnancy plans and cannot contracept as required;
• Subjects who participated in any other clinical study within 3 months prior to screening;
• Subjects with known allergic reactions to the study drug or its excipients;
• Subjects donated or lost ≥ 400 mL 3 months prior to the administration of study drugs; or subjects donated (including aphersis donation) or lost ≥ 200 mL 1 month prior to the administration;
• Subjects who have taken any drug that inhibits or induces hepatic drug-metabolizing enzymes (e.g., inducers: barbiturate, carbamazepine, phenytoin, glucocorticoid, omeprazole; inhibitors: antidepressants like selective serotonin reuptake inhibitor (SSRI), cimetidine, diltiazem macrolides, nitroimidazoles, sedative-hypnotic drugs, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration; or subjects who have taken any prescription, over-the-counter, and herbal medications other than those listed above within 14 days prior to administration;
• Alcoholics or regular drinkers within 3 months, i.e., those who comsume more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of liquor with 40% ABV or 150 mL of wine), or those who have a positive result in breath alcohol test;
• Use of any medication, including prescription, over-the-counter, vitatmins, herbal and/or mineral supplements, dietary supplements (and/or grape fruit juice) within 14 days prior to the first administration, in the Investigator's judgment, which may influence study results or subjects' safety;
• Any other clinical condition that, in the inverstigator's judgement, would potentially compromise study compliance or the abilityti evaluate safety and efficacy.

Sponsors & Collaborators

• Frontier Biotechnologies Inc.: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

FB2001

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yun Liu

  Shanghai Xuhui Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 19, 2022
• Study Start: December 29, 2021
• Primary Completion: April 27, 2022
• Study Completion: June 2, 2022
• Last Updated: July 6, 2022

Record last verified: 2022-06

Locations

CN (1)