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A Study to Evaluate the Safety and Tolerability of KJ103 in Healthy Adults

NCT05274659 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-08-13

No results posted yet for this study

Summary

This is a randomized, single-blinded, placebo controlled, single ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) and immunogenicity of KJ103 in healthy subjects.

Conditions

  • Healthy

Interventions

DRUG

KJ103

Recombinant Immunoglobulin G Cleaving Enzyme

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Shanghai Bao Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Paul Hamilton · New Zealand Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-05-19
Primary Completion
2023-03-18
Completion
2023-08-18

Countries

  • New Zealand

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 NCT05274659 on ClinicalTrials.gov