Idiopathic Pulmonary Fibrosis
Conditions
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.
Interventions
Single dose intravenously infused on day 1
DRUGPlacebo
Single dose of matching placebo intravenously infused on day 1
Sponsors
Mabwell (Shanghai) Bioscience Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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 26.0 kg/m2, inclusive. 3. In good health determined by the investigator based on a medical evaluation.
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, treponema pallidum antibody or human immunodeficiency virus (HIV) antibody 7. History of active tuberculosis, or participants with active or latent tuberculosis infection during screening 8. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) as assessed by CTCAE v5.0 | up to Day113 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to reach Cmax (Tmax) | up to Day113 | To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants. |
| Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) | up to Day113 | To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants. |
| Terminal elimination half-life (t1/2) | up to Day113 | To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants. |
| AUC from time 0 extrapolated to infinity (AUC0-inf) | up to Day113 | To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants. |
| Maximum Plasma Concentration (Cmax) | up to Day113 | To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in healthy adult participants. |
| Apparent clearance (CL) | up to Day113 | To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants. |
| Volume of distribution (Vz) | up to Day113 | To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants. |
| Incidence of antidrug antibodies (ADA) at specified timepoints relative to baseline | up to Day113 | To determine the immunogenicity of 9MW3811. |
| Terminal elimination rate constant (λz) | up to Day113 | To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants. |
Countries
China
Outcome results
None listed