Evaluating the safety and tolerability of 9MW3811 in healthy adults
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
This study is testing a new drug called 9MW3811 in healthy adults to see if it's safe and how well it's tolerated by the body.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Mabwell (Shanghai) Bioscience Co., Ltd. Industry-sponsored |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT05912049 on ClinicalTrials.gov |
What this trial studies
This clinical trial is designed to assess the safety, tolerability, pharmacokinetics, and immunogenicity of a single ascending dose of 9MW3811 in healthy adult participants. The study will involve administering the drug or a placebo to evaluate how well it is tolerated and its effects on the body. Participants will be closely monitored for any adverse reactions or side effects throughout the trial. The findings will help determine the viability of 9MW3811 for further development in treating conditions like idiopathic pulmonary fibrosis.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy male and female adults aged 18 to 55 with specific weight and BMI criteria.
Not a fit: Patients with significant medical histories or allergies to biological agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of a new treatment option for patients with idiopathic pulmonary fibrosis.
How similar studies have performed: While this approach is focused on a specific drug, similar studies evaluating the safety of new treatments have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Suzhou, Jiangsu
- The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.