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A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of 9MW3811 in Healthy Subjects
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.
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
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
| DRUG: 9MW3811 injection
|
PLACEBO_COMPARATOR: placebo
| DRUG: Placebo
|
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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