NCT06277167

A Phase I Study 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Kexing Biopharm Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

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

Conditions

• Healthy Participants

Interventions

Type	Name	Description
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 placebo	Participants will receive Human interferon alfa 1b inhalation solution placebo 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).
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).

Timeline

• Start date: 2023-01-07
• Primary completion: 2023-04-21
• Completion: 2023-04-21
• First posted: 2024-02-26
• Last updated: 2024-05-01

Locations

1 site across 1 country: China