A Study to Evaluate the Safety, Tolerability, Pharmacokinetic Properties and Immunogenicity of 9MW3811 in Healthy Subjects
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Maximum Plasma Concentration (Cmax) [up to Day113]
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in healthy adult participants.
- 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.
- Terminal elimination rate constant (λz) [up to Day113]
To determine the 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.
Eligibility Criteria
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.
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In good health determined by the investigator based on a medical evaluation.
Exclusion Criteria:
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Clinically significant histories determined by the investigator of cardiovascular, hepatic, renal, gastrointestinal, neurological, respiratory, hematological, endocrinological, immunological, metabolic, and musculoskeletal abnormalities.
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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.
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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)
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Participants who have been vaccinated within 4 weeks prior to screening or who are scheduled to be vaccinated during the study
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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
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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
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History of active tuberculosis, or participants with active or latent tuberculosis infection during screening
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China | 215031 |
Sponsors and Collaborators
- Mabwell (Shanghai) Bioscience Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 9MW3811-2023-CP103