A Phase I Study in Healthy Participants

PHASE1CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

January 7, 2023

Primary Completion Date

April 21, 2023

Study Completion Date

April 21, 2023

Conditions
Healthy Participants
Interventions
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).

Trial Locations (1)

Unknown

The Third Hospital of Changsha, Changsha

All Listed Sponsors
collaborator

Guoxin Pharmaceutical Technology (Beijing) Co., Ltd.

UNKNOWN

collaborator

The Third Hospital of Changsha

UNKNOWN

collaborator

Beijing SSYP Data Technology Development Co.,Ltd.

UNKNOWN

collaborator

United-Power Pharma Tech(Shanghai)Co., Ltd.

UNKNOWN

lead

Kexing Biopharm Co., Ltd.

INDUSTRY

NCT06277167 - A Phase I Study in Healthy Participants | Biotech Hunter | Biotech Hunter