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A Phase I Study of XJ101 in Chinese Healthy Subjects

NCT06014736 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-06-14

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-parallel intervention clinical study that will include approximately 38 healthy subjects based on inclusion and exclusion criteria. Subjects will be assigned to one of four different dosage cohorts. Subjects in each cohort will randomly be given experimental drug or a placebo.

Conditions

  • Staphylococcus Aureus Bloodstream Infection

Interventions

DRUG

XJ101 for Injection

XJ101 is a recombinant humanized single domain antibody-Fc (human immunoglobulin G1 type) fusion protein.

DRUG

Placebo

Placebo contains only excipients.

Sponsors & Collaborators

  • Starmab biologics（Shanghai）Co,.ltd

    lead INDUSTRY

Principal Investigators

  • Ding xueying · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-08-15
Primary Completion
2024-03-26
Completion
2024-09-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06014736 on ClinicalTrials.gov