A Study of FB2001 for Inhalation in Healthy Chinese Adults

NCT05583812 | Completed Phase 1

• 1 other identifier: FB2001-103
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

FB2001 is a novel inhalable preparation being developed for COVID-19 treatment. A Double-Blinded, Randomized, and Placebo-Controlled Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics Profile of Single and Multiple Ascending Doses of FB2001 in Healthy Chinese Adults

Conditions

COVID-19 Pandemic

Outcome Measures

Primary Outcomes (3)

• Safety and tolerability after single and multiple doses of FB2001 in healthy subjects

  Assessment of safety by monitoring the incidence of AE after drug administration

  Day 7 or Day 14

• Pharmacokinetic parameter (AUC0-t)

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

  Day 7 or Day 14

• Pharmacokinetic parameter (Cmax)

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

  Day 7 or Day 14

Study Arms (4)

SAD Dose 1

EXPERIMENTAL

Subjects will receive FB2001 or placebo for inhalation once on DAY 1

Drug: FB2001 for inhalation; Drug: FB2001 for inhalation placebo

SAD Dose 2

EXPERIMENTAL

Subjects will receive FB2001 or placebo for inhalation once on DAY 1

Drug: FB2001 for inhalation; Drug: FB2001 for inhalation placebo

MAD Dose 1

EXPERIMENTAL

Subjects will receive FB2001 or placebo for inhalation twice daily during the dosing period

Drug: FB2001 for inhalation; Drug: FB2001 for inhalation placebo

MAD Dose 2

EXPERIMENTAL

Subjects will receive FB2001 or placebo for inhalation twice daily during the dosing period

Drug: FB2001 for inhalation; Drug: FB2001 for inhalation placebo

Interventions

FB2001 for inhalation DRUG

FB2001 once or twice daily inhalation

Also known as: DC402234

MAD Dose 1; MAD Dose 2; SAD Dose 1; SAD Dose 2

FB2001 for inhalation placebo DRUG

FB2001 placebo once or twice daily inhalation

MAD Dose 1; MAD Dose 2; SAD Dose 1; SAD Dose 2

Eligibility Criteria

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

You may qualify if:

• Healthy Chinese male and female volunteers aged 18 to 60 years (including the threshold);
• Male weight ≥ 50 kg and female weight ≥ 45 kg with body mass index (BMI) = weight (kg)/height2 (m2) BMI within the range of 19 to 26 kg/m2 (including the threshold);
• Voluntary participation in the trial and full understanding of the trial content, process and possible adverse effects;
• Willing to cooperate and be able to participate in the study, comply with all requirements of the program, and sign informed consent.

You may not qualify if:

• Participation in any clinical trial within 3 months prior to the administration of the drug;
• Previous history of respiratory disease such as acute exacerbation of chronic obstructive pulmonary disease, pulmonary fibrosis, pulmonary hypertension, pulmonary oedema, interstitial lung lesions, bronchial asthma, paradoxical bronchospasm, or pharyngeal ulceration, oedema, or previous pharyngeal, tracheal/bronchial and pulmonary surgery which the investigator considers to be clinically significant;
• A history of cardiovascular, endocrine, neurological, digestive, genitourinary, haematological, immunological (including personal or family history of hereditary immunodeficiency), or metabolic abnormalities which the investigator considers to be clinically significant;
• Volunteers with a history of allergy to the product and excipients, or a history of hypersensitivity to drugs, foods or other substances;
• Volunteers with a history of intolerance to venipuncture or needle phobia and bloodsickness；
• Volunteers who have undergone surgery within 6 months prior to dosing which in the judgment of the investigator would interfere with the absorption, distribution, metabolism, or excretion, or who have undergone or are scheduled to undergo surgery during the study period within 4 weeks prior to dosing；
• Volunteers having used any medication (including prescription, over-the-counter, herbal, nutraceuticals, etc.) within 14 days prior to administration of the experimental drug；
• volunteers having used any drug metabolism inhibitors or inducers within 30 days prior to the administration of the drug；
• Volunteers receiving a vaccine or attenuated vaccine within 14 days prior to dosing, or planning to have a vaccine administered during the trial；
• Volunteers having donated or lost blood (\>400 mL) within 3 months prior to drug administration or intending to donate blood or blood components during or up to 3 months after the end of the trial；
• substance abusers or having used drugs within 1 year prior to dosing；
• smokers, or unable to stop using any tobacco-based products during the trial；
• alcoholics or regular drinkers of alcohol within 6 months prior to the administration；
• Volunteers consuming excessive amounts of tea, coffee and/or caffeinated beverages on a daily basis or requiring continued drinking during the trial；
• volunteers having ingested food within 7 days prior to administration that may interfere with the metabolism of the drug in vivo or will be unwilling to stop consuming these foods during the trial.

Sponsors & Collaborators

• Frontier Biotechnologies Inc.: lead

Study Sites (1)

The Third Hospital of Changsha

Changsha, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

FB2001; Inhalation

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

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Xin Li, PhD

  The Third Hospital of Changsha

  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: October 8, 2022
• First Posted: October 18, 2022
• Study Start: October 21, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: January 11, 2023

Record last verified: 2022-09

Locations

CN (1)