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Phase I of XKH001Injection in Healthy Adults

NCT05128409 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2023-04-12

No results posted yet for this study

Summary

XKH001is a recombinant humanized monoclonal IgG1 antibody for subcutaneous injection. XKH001 specifically blocks interleukin-25 from binding to its receptors.

To evaluate the safety, tolerability, pharmacokinetics (PK) of single ascending doses of XKH001 injection following subcutaneous administration

Conditions

  • Healthy Adults

Interventions

DRUG

XKH001 Injection

0.5mg/kg: 3Subjects,1Sentinel Participants 1.67mg/kg: 6Subjects, ,1Sentinel Participants 3.34mg/kg: 6Subjects,1Sentinel Participants 5.0mg/kg: 6Subjects, ,1Sentinel Participants 10.0mg/kg: 6Subjects,1Sentinel Participants

DRUG

XKH001Placebo Injection

1.67mg/kg: 2Subjects,1Sentinel Participants 3.34mg/kg: 2Subjects,1Sentinel Participants 5.0mg/kg: 2Subjects,1Sentinel Participants 10.0mg/kg: 2Subjects, 1Sentinel Participants

Sponsors & Collaborators

  • Beijing Kanova Biopharmaceutical Co., LTD

    lead INDUSTRY

Principal Investigators

  • Yanhua Ding, MD · The First Hospital of Jilin University Phase I Clinical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2023-03-07
Primary Completion
2024-10-01
Completion
2024-12-01
FDA Drug
Yes

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 NCT05128409 on ClinicalTrials.gov