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A Phase I Study in Healthy Participants

NCT06277167 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-05-01

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Guoxin Pharmaceutical Technology (Beijing) Co., Ltd.

    collaborator UNKNOWN

  • The Third Hospital of Changsha

    collaborator UNKNOWN

  • Beijing SSYP Data Technology Development Co.,Ltd.

    collaborator UNKNOWN

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

    collaborator UNKNOWN

  • Kexing Biopharm Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-07
Primary Completion
2023-04-21
Completion
2023-04-21

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06277167 on ClinicalTrials.gov