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Trial Title:
A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of 9MW3811 in Healthy Subjects
NCT ID:
NCT05740475
Condition:
Pulmonary Fibrosis
Tumor
Conditions: Official terms:
Pulmonary Fibrosis
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
9MW3811 injection
Description:
Single dose intravenously infused on day 1
Arm group label:
9MW3811 injection
Intervention type:
Drug
Intervention name:
Placebo
Description:
Single dose of matching placebo intravenously infused on day 1
Arm group label:
placebo
Summary:
This is a first-in-human, single ascending dose study of 9MW3811, the primary objective
of which is to evaluate the safety and tolerability of 9MW3811 in healthy adult
participants.
Detailed description:
The single ascending dose study will comprise 4 dose cohorts of 8 healthy participants
each. In each cohort, participants will be randomized to receive 9MW3811 or placebo by
6:2.
Criteria for eligibility:
Criteria:
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.
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
55 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Scientia Clinical Research
Address:
City:
Randwick
Country:
Australia
Status:
Recruiting
Contact:
Last name:
PUJA MOTWANI
Email:
puja.motwani@scientiaclinicalresearch.com.au
Investigator:
Last name:
Christopher Argent
Email:
Principal Investigator
Start date:
March 20, 2023
Completion date:
September 2023
Lead sponsor:
Agency:
Mabwell (Shanghai) Bioscience Co., Ltd.
Agency class:
Industry
Source:
Mabwell (Shanghai) Bioscience Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05740475
