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

Study Overview
=================
Brief Summary
-----------------
This is a single ascending dose study of 9MW3811, the primary objective of which is to evaluate the safety and tolerability of 9MW3811 in healthy adult participants.

Official Title
-----------------
A Phase 1, Randomized, Double-blind，Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Immunogenicity of 9MW3811 in Healthy Participants

Conditions
-----------------
Idiopathic Pulmonary Fibrosis

Intervention / Treatment
-----------------
* Drug: 9MW3811 Injection
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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 26.0 kg/m2, inclusive. In good health determined by the investigator based on a medical evaluation. 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, treponema pallidum antibody or human immunodeficiency virus (HIV) antibody History of active tuberculosis, or participants with active or latent tuberculosis infection during screening 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 9MW3811 Injection<br>single dose escalation for experimental drug | Drug: 9MW3811 Injection<br>* Single dose intravenously infused on day 1<br>|
| Placebo Comparator: Placebo<br>matching placebo administration for control | Drug: Placebo<br>* Single dose of matching placebo intravenously infused on day 1<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) | To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in healthy adult participants. | up to Day113 | 
| Time to reach Cmax (Tmax) | To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants. | up to Day113 | 
| 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 Day113 | 
| Terminal elimination half-life (t1/2) | To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants. | up to Day113 | 
| 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 Day113 | 
| Terminal elimination rate constant (λz) | To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants. | up to Day113 | 
| Apparent clearance (CL) | To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants. | up to Day113 | 
| Volume of distribution (Vz) | To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants. | up to Day113 | 
| Incidence of antidrug antibodies (ADA) at specified timepoints relative to baseline | To determine the immunogenicity of 9MW3811. | up to Day113 |