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A Clinical Study in Healthy Subjects to Evaluate 9MW1911 Injection

NCT05170243 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-12-11

No results posted yet for this study

Summary

This is a Phase 1, randomized, placebo-controlled study, enrolling approximately 38 healthy adult subjects (18-65 yrs). The purpose of this study is to evaluate the safety, tolerability and PK of single ascending dose of 9MW1911 administered intravenously (IV) in healthy adult volunteers. All subjects will be followed up for safety from the time of Informed Consent through 113 days post dose.

Conditions

Interventions

DRUG

9MW1911 Injection

Single dose intravenously on day 1

DRUG

9MW1911 Injection Placebo

Single dose of matching placebo intravenously on day 1

Sponsors & Collaborators

  • Mabwell (Shanghai) Bioscience Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Wang Shuhai, Ph.D · Mabwell (Shanghai) Bioscience Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-01-21
Primary Completion
2022-07-03
Completion
2022-10-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05170243 on ClinicalTrials.gov