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A Phase Ia Clinical Study to Evaluate the Safety, Tolerability, PK and Immunogenicity of YBSW015 in Healthy Subjects

NCT05369754 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-05-11

No results posted yet for this study

Summary

This is phase Ia study to research YBSW015 injection which is a monomolecular bispecific antibody. The Primary objective is to evaluate the safety and tolerability of YBSW015 injection after a single intravenous injection at different doses in healthy subjects.

The Secondary objective is to evaluate the pharmacokinetic characteristics and immunogenicity of different doses of YBSW015 injection after a single intravenous injection in healthy subjects. This study is a single-center, randomized, double-blind, placebo-controlled, single-dose escalation clinical trial.

Conditions

  • Coronavirus Disease 2019

Interventions

BIOLOGICAL

YBSW015 injection

Prepared YBSW015 injection is intravenously injected by an infusion pump or gravity infusion with intravenous infusion of 250 mL for 60 min±10 min.

Sponsors & Collaborators

  • Yabao Pharmaceutical Group

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2022-07-31
Primary Completion
2023-01-31
Completion
2023-02-28

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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 NCT05369754 on ClinicalTrials.gov