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A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of 9MW3811 in Healthy Subjects

PHASE1RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Male or female participants between 18 and 55 years of age, inclusive.

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.

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

Clinically significant histories determined by the investigator of cardiovascular, hepatic, renal, gastrointestinal, neurological, respiratory, hematological, endocrinological, immunological, metabolic, and musculoskeletal abnormalities.

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.

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)

Participants who have been vaccinated within 4 weeks prior to screening or who are scheduled to be vaccinated during the study

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

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

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)

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)

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : Yes

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-03-20

Primary completion: 2023-09-01

Study completion finish: 2023-09-01

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT05740475

Intervention or treatment

DRUG: 9MW3811 injection

DRUG: Placebo

Conditions

• Pulmonary Fibrosis
• Tumor

Condition: Pulmonary Fibrosis, Tumor
DRUG: 9MW3811 injection and other drugs
Randwick, New South Wales, Australia
Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

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Find a site

Closest Location:

Scientia Clinical Research

Research sites nearby

Select from list below to view details:

Scientia Clinical Research
Randwick, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 9MW3811 injection single dose escalation for experimental drug	DRUG: 9MW3811 injection Single dose intravenously infused on day 1
PLACEBO_COMPARATOR: placebo matching placebo administration for control	DRUG: Placebo Single dose of matching placebo intravenously infused on day 1

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Incidence of adverse events (AEs) as assessed by CTCAE v5.0	An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	up to Day113
Number of participants with abnormal clinically significant results from physical examination	The physical examinations will include examination of the following: head, eyes, ears, nose and throat, neck (including thyroid \& nodes), cardiovascular system, dermatological system, musculoskeletal system, respiratory system, gastrointestinal system, neurological system and renal system.	up to Day113
Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters	The examination indicators include heart rate, PR, QRS, uncorrected QT, and QTcF \[corrected by Fridericia formula, QTcF = QT/(RR\^0.33), RR is the standardized heart rate value, which is obtained by dividing 60 by the heart rate\].	up to Day113
Number of participants with abnormally clinical vital signs	Vital signs measurements will include pulse rate, respiration rate, blood pressure (systolic and diastolic blood pressure) and body temperature.	up to Day113
Number of participants with abnormal clinically significant clinical laboratory results	Clinical laboratory tests include hematology, urinalysis, blood chemistry, coagulation function.	up to Day113

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Maximum Plasma Concentration (Cmax)	To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in healthy adult participants.	up to Day 113
Time to reach Cmax (Tmax)	To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.	up to Day 113
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)	To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.	up to Day 113
Terminal elimination half-life (t1/2)	To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.	up to Day 113
AUC from time 0 extrapolated to infinity (AUC0-inf)	To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.	up to Day 113
Terminal elimination rate constant (λz)	To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.	up to Day 113
Apparent clearance (CL)	To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.	up to Day 113
Volume of distribution (Vz)	To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.	up to Day 113
Incidence of antidrug antibodies (ADA) at specified timepoints relative to baseline	To determine the immunogenicity of 9MW3811.	up to Day 113

Frequently Asked Questions

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References

Clinical Trials Gov: A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of 9MW3811 in Healthy Subjects