A Phase I Study of Human Interferon Alfa 1b Inhalation Solution in Healthy Participants

A Randomized, Double-Blind, Placebo-Controlled Phase-I Clinical Study to Evaluate the Tolerability, Safety and PK Profiles of Human Interferon Alfa 1b Inhalation Solution in Healthy Adult Subjects After Administration of Single Ascending Doses and Multiple Ascending Doses

A Randomized, Double-Blind, Placebo-Controlled Phase-I Clinical Study to Evaluate the Tolerability, Safety and PK Profiles of Human interferon alfa 1b inhalation solution in Healthy Adult Subjects after Administration of Single Ascending Doses and Multiple Ascending Doses

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Human interferon alfa 1b inhalation solution; Drug: Human interferon alfa 1b inhalation solution; Drug: Human interferon alfa 1b inhalation solution placebo; Drug: Human interferon alfa 1b inhalation solution placebo

Detailed Description

Primary objective:To evaluate the tolerability and safety of single and multiple aerosol inhalation of Human interferon alfa 1b inhalation solution in healthy adult subjects.

Secondary objectives: To evaluate the pharmacokinetic (PK) profiles of single and multiple aerosol inhalation of Human interferon alfa 1b inhalation solution in healthy adult subjects and to evaluate the immunogenicity of single and multiple aerosol inhalation of Human interferon alfa 1b inhalation solution in healthy adult subjects

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Changsha, China
    • The Third Hospital of Changsha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy adult males or females aged 18-45 years;
2. Male body weight ≥45 kg, male body weight ≥50 kg, and body mass index (BMI): 19.0-26.0 kg/m2 (both inclusive), BMI =body weight (kg)/height 2 (m2);
3. The subjects voluntarily participate in the study and sign an informed consent form before the study.

Exclusion Criteria:

1. Subjects who participated in any clinical studies of drugs or took study drugs within 3 months prior to the administration of study drug;
2. Subjects who have undergone surgery within 3 months prior to screening or who plan to undergo surgery during the study or who have undergone surgery that would affect the absorption, distribution, metabolism, and excretion of drugs; subjects with a previous history of diseases of cardiovascular system, blood and lymphatic system, respiratory system, urinary system, endocrine, immune, mental and nervous system (such as epilepsy) that are clinically significant;
3. Subjects with a history of respiratory system diseases, such as acute exacerbation of chronic obstructive pulmonary disease, pulmonary fibrosis, pulmonary hypertension, pulmonary edema, pulmonary interstitial disease, bronchial asthma, paradoxical bronchospasm, or throat ulcer and edema, or subjects with previous surgery of throat, trachea/bronchi and lung, or subjects with upper and lower respiratory tract infection and acute sinusitis caused by virus or bacteria within the 4 weeks prior to the use of study drug that are clinically significant or render them unsuitable to participate in the study in the opinion of the investigator;
4. Subjects with ocular diseases or thyroid-related diseases that are clinically significant or render them unsuitable to participate in the study in the opinion of the investigator;
5. Subjects with a history of drug allergy (antibiotics, interferon products, etc.), or a specific history of allergy (asthma, urticaria, eczema, etc.), or allergic constitution (such as allergy to two or more drugs, food, pollen, etc.);
6. Subjects who cannot tolerate aerosol inhalation;
7. Subjects who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or vitamins within14 days prior to screening;
8. Subjects who have received vaccine within 4 weeks prior to the first dose, or subjects who plan to receive vaccine within 4 weeks after the last dose;
9. Subjects who have had non-physiological blood loss of ≥300 mL within 3 months before the first dose (including trauma, blood collection, blood donation); or subjects who plan to donate blood during the study or within 30 days after the last dose;
10. Subjects who have had a history of drug use or abuse within 6 months prior to screening;
11. Subjects who have smoked within 3 months prior to screening, or who cannot stop using any tobacco products during the study;
12. Subjects who have consumed more than 14 glasses of alcohol per week (1 glass =150 mL wine, or 360 mL beer, or 45 mL spirits) within 3 months prior to screening;
13. Subjects who cannot tolerate venipuncture for blood collection or have potential blood collection difficulties, or subjects who feel dizzy and sick at the sight of blood or needle;
14. Subjects who have special requirements for diet and cannot follow a standardized diet;
15. Subjects who have a birth plan, or are unable to voluntarily take effective contraceptive measures, or have a sperm/egg donation plan during the study period and within 3 months after the last dose; female subjects who are pregnant or lactating;
16. Subjects with clinically significant abnormalities on physical examinations, electrocardiograms, vital signs, chest X-rays, lung function, and laboratory tests (as judged by the clinician);
17. Pulmonary function test: subjects with measured/predicted FEV1 ≤80% or FVC≤ 80% of expected value;
18. Subjects who have positive urine nicotine test results;
19. Subjects who have positive urine drug test results;
20. Subjects who have positive alcohol breath results;
21. Subjects who cannot use aerosol device correctly or who do not pass the aerosol dosing training;
22. Subjects who cannot complete this study due to other reasons, or subjects who are unsuitable to participate in this clinical study due to other various reasons;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Human interferon alfa 1b inhalation solution (SAD); Human interferon alfa 1b inhalation solution：200,000 IU, 600,000 IU, 1,200,000 IU, and 1,80,000 IU dose groups	Drug: Human interferon alfa 1b inhalation solution; Participants will receive Human interferon alfa 1b inhalation solution orally for a single dose.; Drug: Human interferon alfa 1b inhalation solution; Participants in the 1,200,000 IU and 1,800,000 IU dose groups will be given multiple consecutive doses after a single dose safety assessment, i.e. Human interferon alfa 1b inhalation solution administered by aerosol inhalation twice a day at the dose of the corresponding group, for 5 consecutive days respectively (only one morning dose on the last day, for a total of 10 doses during the study).
Placebo Comparator: Human interferon alfa 1b inhalation solution placebo (SAD); Human interferon alfa 1b inhalation solution placebo ：200,000 IU, 600,000 IU, 1,200,000 IU, and 1,80,000 IU dose groups	Drug: Human interferon alfa 1b inhalation solution placebo; Participants will receive Human interferon alfa 1b inhalation solution placebo orally for a single dose.; Drug: Human interferon alfa 1b inhalation solution placebo; Participants in the 1,200,000 IU and 1,800,000 IU dose groups will be given multiple consecutive doses after a single dose safety assessment, i.e. Human interferon alfa 1b inhalation solution placebo administered by aerosol inhalation twice a day at the dose of the corresponding group, for 5 consecutive days respectively (only one morning dose on the last day, for a total of 10 doses during the study).
Experimental: Human interferon alfa 1b inhalation solution (MAD); Human interferon alfa 1b inhalation solution drug product：1,200,000 IU, and 1,80,000 IU dose groups	Drug: Human interferon alfa 1b inhalation solution; Participants will receive Human interferon alfa 1b inhalation solution orally for a single dose.; Drug: Human interferon alfa 1b inhalation solution; Participants in the 1,200,000 IU and 1,800,000 IU dose groups will be given multiple consecutive doses after a single dose safety assessment, i.e. Human interferon alfa 1b inhalation solution administered by aerosol inhalation twice a day at the dose of the corresponding group, for 5 consecutive days respectively (only one morning dose on the last day, for a total of 10 doses during the study).
Placebo Comparator: Human interferon alfa 1b inhalation solution placebo (MAD); Human interferon alfa 1b inhalation solution placebo ：1,200,000 IU, and 1,80,000 IU dose groups	Drug: Human interferon alfa 1b inhalation solution placebo; Participants will receive Human interferon alfa 1b inhalation solution placebo orally for a single dose.; Drug: Human interferon alfa 1b inhalation solution placebo; Participants in the 1,200,000 IU and 1,800,000 IU dose groups will be given multiple consecutive doses after a single dose safety assessment, i.e. Human interferon alfa 1b inhalation solution placebo administered by aerosol inhalation twice a day at the dose of the corresponding group, for 5 consecutive days respectively (only one morning dose on the last day, for a total of 10 doses during the study).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TEAEs	The adverse events and incidence of treatment-emergent adverse events(TEAEs)	Day 1 up to 29 or Day 1 up to 32
(ADRs)	The adverse events and incidence of adverse drug reactions (ADRs)	Day 1 up to 29 or Day 1 up to 32
(SAE)	The adverse events and incidence of serious adverse events (SAE)	Day 1 up to 29 or Day 1 up to 32
TEAEs that lead to subject discontinuation from the study	The adverse events and incidence of TEAEs that lead to subject discontinuation from the study	Day 1 up to 29 or Day 1 up to 32

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax After a Single Dose of GB05 Drug Product	The maximum concentration (Cmax) of GB05 Drug Product	Day 1 up to 3
Tmax After a Single Dose of GB05 Drug Product	The maximum concentration (Tmax) of GB05 Drug Product	Day 1 up to 3
AUC0-t and AUC0-inf After a Single Dose of GB05 Drug Product	The area under the concentration-time curve (AUC0-t and AUC0-inf) of GB05 Drug Product.	Day 1 up to 3
t1/2 After a Single Dose of GB05 Drug Product	The elimination half-life (t1/2) of GB05 Drug Product	Day 1 up to 3
Ke After a Single Dose of GB05 Drug Product	The elimination rate constant (Ke) of GB05 Drug Product	Day 1 up to 3
Vd After a Single Dose of GB05 Drug Product	The apparent distribution volume (Vd) of GB05 Drug Product.	Day 1 up to 3
MRT After a Single Dose of GB05 Drug Product	The average residence time (MRT) of GB05 Drug Product	Day 1 up to 3
CL After a Single Dose of GB05 Drug Product	The clearance rate (CL) of GB05 Drug Product	Day 1 up to 3
Cmax,ss After Multiple Doses of GB05 Drug Product	The maximum concentration at steady state (Cmax,ss) of GB05 Drug Product	Day 1 up to 10
Cmin,ss After Multiple Doses of GB05 Drug Product	The minimum concentration at steady state (Cmin,ss) of GB05 Drug Product	Day 1 up to 10
Css_av After Multiple Doses of GB05 Drug Product	The average steady-state plasma concentration (Css_av) of GB05 Drug Product	Day 1 up to 10
DF After Multiple Doses of GB05 Drug Product	The degree of fluctuation in the concentration during the dosing interval (DF) of GB05 Drug Product	Day 1 up to 10
(Cmax,ss-Cmin,ss)/Cmin,ss After Multiple Doses of GB05 Drug Product	The fluctuation amplitude [(Cmax,ss-Cmin,ss)/Cmin,ss] of GB05 Drug Product	Day 1 up to 10
ADA	The Number and Percentage of Participants of anti-drug antibody (ADA)	Day 1 up to 29 or Day 1 up to 32
NAb	The Number and Percentage of Participants of neutralizing antibody (NAb).	Day 1 up to 29 or Day 1 up to 32

Collaborators and Investigators

• Sponsor: Kexing Biopharm Co., Ltd.
• Collaborators: The Third Hospital of Changsha; Guoxin Pharmaceutical Technology (Beijing) Co., Ltd.; Beijing SSYP Data Technology Development Co.,Ltd.; United-Power Pharma Tech（Shanghai）Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2023
• Primary Completion (Estimated): May 21, 2024
• Study Completion (Estimated): May 21, 2024

Study Registration Dates

• First Submitted: February 2, 2024
• First Submitted That Met QC Criteria: February 17, 2024
• First Posted (Estimated): February 26, 2024

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 17, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Interferons; Interferon-alpha; Interferon-alfa-1b; Pharmaceutical Solutions
• Other Study ID Numbers: KXZY-GB05-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No