A Phase I Study in Healthy Participants

NCT06277167 | Completed Phase 1

• 1 other identifier: KXZY-GB05-101
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (15)

• Cmax After a Single Dose of GB05 Drug Product

  Day 1 up to 3

• Tmax After a Single Dose of GB05 Drug Product

  Day 1 up to 3

• AUC0-t and AUC0-inf After a Single Dose of GB05 Drug Product

  Day 1 up to 3

• t1/2 After a Single Dose of GB05 Drug Product

  Day 1 up to 3

• Ke After a Single Dose of GB05 Drug Product

  Day 1 up to 3

Study Arms (4)

Human interferon alfa 1b inhalation solution (SAD)

EXPERIMENTAL

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

Human interferon alfa 1b inhalation solution placebo (SAD)

PLACEBO COMPARATOR

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

Human interferon alfa 1b inhalation solution (MAD)

EXPERIMENTAL

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

Human interferon alfa 1b inhalation solution placebo (MAD)

PLACEBO COMPARATOR

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

Interventions

Human interferon alfa 1b inhalation solution DRUG

Participants will receive Human interferon alfa 1b inhalation solution orally for a single dose.

Human interferon alfa 1b inhalation solution (SAD)

Human interferon alfa 1b inhalation solution placebo DRUG

Participants will receive Human interferon alfa 1b inhalation solution placebo orally for a single dose.

Human interferon alfa 1b inhalation solution placebo (SAD)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult males or females aged 18-45 years;
• 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);
• The subjects voluntarily participate in the study and sign an informed consent form before the study.

You may not qualify if:

• Subjects who participated in any clinical studies of drugs or took study drugs within 3 months prior to the administration of study drug;
• 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;
• 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;
• 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;
• 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.);
• Subjects who cannot tolerate aerosol inhalation;
• Subjects who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or vitamins within14 days prior to screening;
• 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;
• 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;
• Subjects who have had a history of drug use or abuse within 6 months prior to screening;
• Subjects who have smoked within 3 months prior to screening, or who cannot stop using any tobacco products during the study;
• 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;
• 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;
• Subjects who have special requirements for diet and cannot follow a standardized diet;
• 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;

Sponsors & Collaborators

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

Study Sites (1)

The Third Hospital of Changsha

Changsha, China

Location

Related Publications (1)

• Peng H, Zhang W, Lin Y, Li H, Qin S. Safety, Tolerability, and Pharmacokinetics of Nebulized GB05-Human IFNalpha1b Inhalation Solution: A Randomized, Placebo-Controlled, Dose-Escalation Phase I Study in Healthy Chinese Adult Volunteers. Infect Dis Ther. 2024 Sep;13(9):2053-2070. doi: 10.1007/s40121-024-01024-y. Epub 2024 Aug 4.

  PMID: 39097549 DERIVED

Study Design

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

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 26, 2024
• Study Start: January 7, 2023
• Primary Completion: April 21, 2023
• Study Completion: April 21, 2023
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)