A Clinical Study in Healthy Subjects to Evaluate 9MW1911 Injection

NCT05170243 | Completed Phase 1

• 1 other identifier: 9MW1911-2021-CP102
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Asthma; COPD; Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Adverse Event(including serious adverse event)

  The incidence of AEs (adverse events) and SAEs (serious adverse events) from treatment until the last scheduled follow-up visit

  up to day 113

Secondary Outcomes (5)

• PK parameters

  up to day 113

• PK parameters

  up to day 113

• PK parameters

  up to day 113

• PK parameters

  up to day 113

• Incidence of ADAs Against 9MW1911

  up to day 113

Study Arms (2)

9MW1911 Injection

ACTIVE COMPARATOR

Experimental drug administered IV infusion

Drug: 9MW1911 Injection

9MW1911 Injection Placebo

PLACEBO COMPARATOR

Placebo administered IV infusion

Drug: 9MW1911 Injection Placebo

Interventions

9MW1911 Injection DRUG

Single dose intravenously on day 1

9MW1911 Injection

9MW1911 Injection Placebo DRUG

Single dose of matching placebo intravenously on day 1

9MW1911 Injection Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are willing to follow study procedures and sign informed consent voluntarily.
• Male or female subjects aged 18 to 65 years (including 18 and 65 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).
• Female subjects must have a negative β-HCG pregnancy test (Screening and Baseline); Subjects(including their partners) will take effective contraceptive measures voluntarily;Subjects have neither pregnancy plans nor sperm or egg donation plans during the screening period and the next 6 months.

You may not qualify if:

• 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.
• The clinical laboratory tests show any clinical abnormalities, or abnormalities with clinical significance(including but not limited to diseases of digestive tract, kidney, liver, nervous system, blood, endocrine system, cancer, lung, immune system, mental, heart),and judged by the investigator to affect participation in this study.
• Subjects with prolonged QTcF interval (\> 450 ms) on electrocardiogram (ECG) examination, or family history of prolonged QTc syndrome or sudden death.
• Subjects (female) who is pregnant or lactating at screening or during the trial.
• Subjects who have previously used immunosuppressants or monoclonal antibodies for any reason.
• Subjects who used any prescription, over-the-counter, or Chinese herbal medicines within 2 weeks prior to screening.
• Subjects who received any vaccinations within 4 weeks prior to screening, or are scheduled to receive a vaccination during the study.
• Subjects who have undergone surgery within 3 months prior to screening, or plan to undergo surgery during the study.
• Subjects who have a history of drug abuse within 6 months prior to screening.
• Subjects who have used illicit drugs within 3 months prior to screening.
• Subjects who have consumed more than 14 units of alcohol per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL of spirits containing 40% alcohol or 150 mL of wine) within 3 months prior to screening, or who cannot abstain from alcohol during the study.
• Subjects who have smoked more than 5 cigarettes per day within 3 months prior to screening, or who cannot abstain from cigarette product during the study.
• Subjects who have participated in drug or medical devices clinical trials within 3 months prior to screening.
• Subjects who donated or lost blood ≥ 200 mL within 3 months prior to screening, or plan to donate blood within 3 months.
• Subjects whose alcohol breath test results greater than 0.0 mg/100 ml or positive drug screening (morphine, icenarcotics \[methamphetamine\], ketamine, ecstasy \[methylenedioxyamphetamine\], cannabis \[tetrahydrocannabinolate\]).

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Public Health Center

Shanghai, Shanghai Municipality, 200540, China

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• Wang Shuhai, Ph.D

  Mabwell (Shanghai) Bioscience Co., Ltd.

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: December 27, 2021
• Study Start: January 21, 2022
• Primary Completion: July 3, 2022
• Study Completion: October 28, 2022
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)