Clinical trial NCT05740475: A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of 9MW3811 in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pulmonary Fibrosis
Tumor
Lead sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-02-23
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a first-in-human, single ascending dose study of 9MW3811, the primary objective of which is to evaluate the safety and tolerability of 9MW3811 in healthy adult participants.

Detailed description: The single ascending dose study will comprise 4 dose cohorts of 8 healthy participants each. In each cohort, participants will be randomized to receive 9MW3811 or placebo by 6:2.

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)

Primary outcomes:
measure: Incidence of adverse events (AEs) as assessed by CTCAE v5.0
timeFrame: up to Day113
measure: Number of participants with abnormal clinically significant results from physical examination
timeFrame: up to Day113
measure: Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters
timeFrame: up to Day113
measure: Number of participants with abnormally clinical vital signs
timeFrame: up to Day113
measure: Number of participants with abnormal clinically significant clinical laboratory results
timeFrame: up to Day113
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: up to Day 113
measure: Time to reach Cmax (Tmax)
timeFrame: up to Day 113
measure: Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)
timeFrame: up to Day 113
measure: Terminal elimination half-life (t1/2)
timeFrame: up to Day 113
measure: AUC from time 0 extrapolated to infinity (AUC0-inf)
timeFrame: up to Day 113
measure: Terminal elimination rate constant (λz)
timeFrame: up to Day 113
measure: Apparent clearance (CL)
timeFrame: up to Day 113
measure: Volume of distribution (Vz)
timeFrame: up to Day 113
measure: Incidence of antidrug antibodies (ADA) at specified timepoints relative to baseline
timeFrame: up to Day 113
Other outcomes:
measure: Serum interleukin-11 (IL-11) level after administration at specified timepoints relative to baseline
timeFrame: up to Day 113
Locations:
city: Randwick
country: Australia
facility: Scientia Clinical Research
state: New South Wales
Study officials:
References: