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
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
35
Participants will receive Human interferon alfa 1b inhalation solution orally for a single dose.
Participants will receive Human interferon alfa 1b inhalation solution placebo orally for a single dose.
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).
The Third Hospital of Changsha
Changsha, China
TEAEs
The adverse events and incidence of treatment-emergent adverse events(TEAEs)
Time frame: Day 1 up to 29 or Day 1 up to 32
(ADRs)
The adverse events and incidence of adverse drug reactions (ADRs)
Time frame: Day 1 up to 29 or Day 1 up to 32
(SAE)
The adverse events and incidence of serious adverse events (SAE)
Time frame: 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
Time frame: Day 1 up to 29 or Day 1 up to 32
Cmax After a Single Dose of GB05 Drug Product
The maximum concentration (Cmax) of GB05 Drug Product
Time frame: Day 1 up to 3
Tmax After a Single Dose of GB05 Drug Product
The maximum concentration (Tmax) of GB05 Drug Product
Time frame: 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.
Time frame: 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
Time frame: Day 1 up to 3
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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).
Ke After a Single Dose of GB05 Drug Product
The elimination rate constant (Ke) of GB05 Drug Product
Time frame: Day 1 up to 3
Vd After a Single Dose of GB05 Drug Product
The apparent distribution volume (Vd) of GB05 Drug Product.
Time frame: Day 1 up to 3
MRT After a Single Dose of GB05 Drug Product
The average residence time (MRT) of GB05 Drug Product
Time frame: Day 1 up to 3
CL After a Single Dose of GB05 Drug Product
The clearance rate (CL) of GB05 Drug Product
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 1 up to 10
ADA
The Number and Percentage of Participants of anti-drug antibody (ADA)
Time frame: Day 1 up to 29 or Day 1 up to 32
NAb
The Number and Percentage of Participants of neutralizing antibody (NAb).
Time frame: Day 1 up to 29 or Day 1 up to 32