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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05740475




Registration number
NCT05740475
Ethics application status
Date submitted
2/02/2023
Date registered
23/02/2023

Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of 9MW3811 in Healthy Subjects
Scientific title
A Phase 1, First-in-human, Randomized, Double-blind,Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Immunogenicity of 9MW3811 in Healthy Adult Participants
Secondary ID [1] 0 0
9MW3811-2022-CP101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Fibrosis 0 0
Tumor 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 9MW3811 injection
Treatment: Drugs - Placebo

Experimental: 9MW3811 injection - single dose escalation for experimental drug

Placebo comparator: placebo - matching placebo administration for control


Treatment: Drugs: 9MW3811 injection
Single dose intravenously infused on day 1

Treatment: Drugs: Placebo
Single dose of matching placebo intravenously infused on day 1
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of adverse events (AEs) as assessed by CTCAE v5.0
Timepoint [1] 0 0
up to Day113
Primary outcome [2] 0 0
Number of participants with abnormal clinically significant results from physical examination
Timepoint [2] 0 0
up to Day113
Primary outcome [3] 0 0
Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters
Timepoint [3] 0 0
up to Day113
Primary outcome [4] 0 0
Number of participants with abnormally clinical vital signs
Timepoint [4] 0 0
up to Day113
Primary outcome [5] 0 0
Number of participants with abnormal clinically significant clinical laboratory results
Timepoint [5] 0 0
up to Day113
Secondary outcome [1] 0 0
Maximum Plasma Concentration (Cmax)
Timepoint [1] 0 0
up to Day 113
Secondary outcome [2] 0 0
Time to reach Cmax (Tmax)
Timepoint [2] 0 0
up to Day 113
Secondary outcome [3] 0 0
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)
Timepoint [3] 0 0
up to Day 113
Secondary outcome [4] 0 0
Terminal elimination half-life (t1/2)
Timepoint [4] 0 0
up to Day 113
Secondary outcome [5] 0 0
AUC from time 0 extrapolated to infinity (AUC0-inf)
Timepoint [5] 0 0
up to Day 113
Secondary outcome [6] 0 0
Terminal elimination rate constant (?z)
Timepoint [6] 0 0
up to Day 113
Secondary outcome [7] 0 0
Apparent clearance (CL)
Timepoint [7] 0 0
up to Day 113
Secondary outcome [8] 0 0
Volume of distribution (Vz)
Timepoint [8] 0 0
up to Day 113
Secondary outcome [9] 0 0
Incidence of antidrug antibodies (ADA) at specified timepoints relative to baseline
Timepoint [9] 0 0
up to Day 113

Eligibility
Key inclusion criteria
1. Male or female participants between 18 and 55 years of age, inclusive.
2. Male body weight =50.0 kg, or female body weight =45.0 kg, and body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
3. In good health determined by the investigator based on a medical evaluation, including a detailed medical and surgical history, as well as a complete physical examination including vital signs, 12-lead ECG, laboratory evaluations.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Clinically significant histories determined by the investigator of cardiovascular, hepatic, renal, gastrointestinal, neurological, respiratory, hematological, endocrinological, immunological, metabolic, and musculoskeletal abnormalities.
2. Having any history of an allergy to biological agents or any components of study drug; those who have a history of allergies and judged by the investigator to be ineligible for enrolment.
3. Use of any prescription medication 14 days prior to dosing or over-the-counter medication, vitamins, and/or herbal medicines 7 days prior to dosing (Excluding oral contraception, occasional paracetamol, ibuprofen and standard dose of multivitamins at the discretion of the PI or designee)
4. Participants who have been vaccinated within 4 weeks prior to screening or who are scheduled to be vaccinated during the study
5. Participants who received immunosuppressants except for previous use of inhaled or nasal corticosteroids 4 weeks earlier before administration or any oral corticosteroids 8 weeks earlier before administration, and who had received a single dose of monoclonal antibodies for any reason within 1 year prior to screening
6. Participants with one or more clinically significant positive test results of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) antibody
7. History of drug abuse including narcotic and psychiatric drugs within 6 months prior to screening or a positive drug abuse test result at baseline (Morphine, Methamphetamine, Tetrahydrocannabinol acid, Cocaine)
8. Participants with a positive SARS-CoV-2 test prior to admission (polymerase chain reaction (PCR) and/or rapid antigen testing (RAT), per site policy and PI discretion)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2023
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Scientia Clinical Research - Randwick
Recruitment postcode(s) [1] 0 0
- Randwick

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Mabwell (Shanghai) Bioscience Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Christopher Argent
Address 0 0
Country 0 0
Phone 0 0
02 9382 5844
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05740475