Evaluating the safety and tolerability of 9MW3811 in healthy adults

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

This study is testing a new drug called 9MW3811 in healthy adults to see if it's safe and how well their bodies handle it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Randwick, New South Wales)
• Trial ID: NCT05740475 on ClinicalTrials.gov

What this trial studies

This is a first-in-human, single ascending dose evaluation of 9MW3811, focusing on its safety and tolerability in healthy adult participants. The study will involve four dose cohorts, each consisting of eight participants who will be randomized to receive either the drug or a placebo. The primary goal is to assess how well the drug is tolerated and its pharmacokinetic properties. Participants will undergo thorough medical evaluations to ensure they are in good health before enrollment.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy male or 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 a better understanding of 9MW3811's safety profile, paving the way for future treatments for conditions like pulmonary fibrosis and tumors.

How similar studies have performed: While this is a first-in-human study, similar early-phase trials have shown promise in evaluating new drug candidates for safety and tolerability.

Eligibility 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 30.0 kg/m2, inclusive.
3. In good health determined by the investigator based on a medical evaluation, including a detailed medical and surgical history, as well as a complete physical examination including vital signs, 12-lead ECG, laboratory evaluations.

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 or human immunodeficiency virus (HIV) antibody
7. 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, Cocaine)
8. Participants with a positive SARS-CoV-2 test prior to admission (polymerase chain reaction (PCR) and/or rapid antigen testing (RAT), per site policy and PI discretion)

Where this trial is running

Randwick, New South Wales

• Scientia Clinical Research — Randwick, New South Wales, Australia (Recruiting)

Study contacts

• Study coordinator: Christopher Argent

Conditions Pulmonary Fibrosis; Tumor