A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of 9MW3811 in Healthy Subjects

Phase 1

Recruiting

• Conditions: Tumor; Pulmonary Fibrosis
• Interventions: Drug: 9MW3811 injection; Drug: Placebo

• Registration Number: NCT05740475
• Lead Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2023-02-02
• Study First Submitted QC: 2023-02-13
• Study First Posted: 2023-02-23
• Study Start: 2023-03-20
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-12
• Last Update Posted: 2023-06-13
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
9MW3811 injection	9MW3811 injection	single dose escalation for experimental drug
placebo	Placebo	matching placebo administration for control

Primary Outcome Measures

Name	Time	Method
Number of participants with abnormal clinically significant results from physical examination	up to Day113	The physical examinations will include examination of the following: head, eyes, ears, nose and throat, neck (including thyroid \& nodes), cardiovascular system, dermatological system, musculoskeletal system, respiratory system, gastrointestinal system, neurological system and renal system.
Number of participants with abnormal clinically significant clinical laboratory results	up to Day113	Clinical laboratory tests include hematology, urinalysis, blood chemistry, coagulation function.
Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters	up to Day113	The examination indicators include heart rate, PR, QRS, uncorrected QT, and QTcF \[corrected by Fridericia formula, QTcF = QT/(RR\^0.33), RR is the standardized heart rate value, which is obtained by dividing 60 by the heart rate\].
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.
Number of participants with abnormally clinical vital signs	up to Day113	Vital signs measurements will include pulse rate, respiration rate, blood pressure (systolic and diastolic blood pressure) and body temperature.

Secondary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax)	up to Day 113	To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Time to reach Cmax (Tmax)	up to Day 113	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 Day 113	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 Day 113	To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Apparent clearance (CL)	up to Day 113	To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Volume of distribution (Vz)	up to Day 113	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 Day 113	To determine the immunogenicity of 9MW3811.
Terminal elimination half-life (t1/2)	up to Day 113	To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Terminal elimination rate constant (λz)	up to Day 113	To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.

Trial Locations

Locations (1)

Scientia Clinical Research; 🇦🇺 Randwick, New South Wales, Australia