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A Study of IBI311 in Healthy Volunteers

NCT05480579 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-10-11

No results posted yet for this study

Summary

It is designed for Multi-center, double-masked, randomized, placebo- control study with dose escalation phase I trial to evaluate the safety, tolerability, PK and immunogenicity profiles of a single intravenous injection of IBI311 in healthy volunteers.

Conditions

  • Healthy

Interventions

BIOLOGICAL

placebo

Dose4 placebo of single IV injection

BIOLOGICAL

IBI311

Dose2 IBI311 of single IV injection

BIOLOGICAL

IBI311

Dose4 IBI311 of single IV injection

BIOLOGICAL

placebo

Dose3 placebo of single IV injection

BIOLOGICAL

placebo

Dose1 placebo of single IV injection

BIOLOGICAL

IBI311

Dose1 IBI311 of single IV injection

BIOLOGICAL

IBI311

Dose 3 IBI311 of single IV injection

BIOLOGICAL

placebo

Dose2 placebo of single IV injection

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Yongfang Yuan, Ph D. · Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2022-08-10
Primary Completion
2022-11-23
Completion
2023-01-19

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 NCT05480579 on ClinicalTrials.gov