A Clinical Study in Health Subjects to Evaluate 9MW1411 Injection

NCT04784312 | Completed Phase 1

• 1 other identifier: 9MW1411-2020-CP101
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, first time in human study enrolling approximately 42 healthy adult subjects (18-45 yrs) from one study site. The purpose of this study is to evaluate the safety, tolerability and PK of MW14 in healthy adult volunteers administered as a single IV dose compared with placebo, across 5 cohorts. The 5 dose cohorts will enroll sequentially. Subjects will be followed for safety from the time of Informed Consent through 85 days post dose.

Conditions

Staphylococcus Aureus Infection

Outcome Measures

Primary Outcomes (2)

• Adverse Event

  safety evaluation

  12 weeks

• Serious Adverse Event

  safety evaluation

  12 weeks

Study Arms (2)

9MW1411 injection

EXPERIMENTAL

Combination Product: 9MW1411 injection

9MW1411 injection placebo

EXPERIMENTAL

Combination Product: 9MW1411 injection placebo

Interventions

9MW1411 injection COMBINATION_PRODUCT

9MW1411 injection

9MW1411 injection

9MW1411 injection placebo COMBINATION_PRODUCT

9MW1411 injection placebo

9MW1411 injection placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female subjects aged 18 to 45 years (including 18 and 45 years).
• Weight≥50.0 kg for males, or weight≥45.0 kg for females, and body mass index (BMI) in the range of 19.0 \~ 26.0 kg/m2 (including cut-off value).
• The medical history, physical examination, clinical laboratory tests and other tests related study show no abnormalities, or abnormalities without clinical significance.
• Subjects do not have a pregnancy plan, have no sperm and egg donation plans during the screening period and the next 6 months, and take effective contraceptive measures voluntarily.
• Are willing to follow study procedures, signed informed consent voluntarily, and ensure that he/she will complete the study according to the program requirements.

You may not qualify if:

• Prior or current medical conditions:
• Health status: clinically significant histories of heart, liver, kidney, digestive tract, nervous system, respiratory system, blood and lymphatic system, immune system, mental, metabolic, and bone abnormalities.
• Subjects who have a history of allergies to biological agents or any drug components; those who have a history of allergies and judged by the investigator to be ineligible for enrollment.
• Those who undergone acute infection within 2 weeks prior to screening.
• Those with abnormalities in pulmonary imaging examination prior to screening and judged to be clinically significant by the investigator.
• Those who have undergone surgery within 3 months prior to screening, or who plan to undergo surgery during the study.
• Those who cannot tolerate venipuncture or have a history of needle-sickness and blood-sickness.
• Those who have a history of drug abuse within 6 months prior to screening.
• Use of illicit drugs within 3 months prior to screening.
• Those who donated blood within 3 months prior to screening (including component blood), or massive blood loss (≥ 200 mL), or blood transfusions or use of blood products.
• Subject (female) who is pregnant or lactating at screening or during the trial.
• Subjects have a fertility plan or sperm or egg donation plan at screening and within the next 6 months.
• Use of any prescription, over-the-counter, or Chinese herbal medicines within 2 weeks prior to screening.
• Those who have been vaccinated within 4 weeks prior to screening or who are scheduled to be vaccinated during the study.
• Those who have smoked more than 5 cigarettes per day within 3 months prior to screening.

Sponsors & Collaborators

• Mabwell (Shanghai) Bioscience Co., Ltd.: lead
• Huashan Hospital: collaborator

Study Sites (1)

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 5, 2021
• Study Start: April 16, 2021
• Primary Completion: August 17, 2021
• Study Completion: August 17, 2021
• Last Updated: June 15, 2022

Record last verified: 2021-12

Locations

CN (1)