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

Phase 1

Recruiting

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: 9MW3811 Injection; Drug: Placebo

• Registration Number: NCT05912049
• Lead Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-12
• Study First Submitted QC: 2023-06-12
• Study First Posted: 2023-06-22
• Study Start: 2023-07-26
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-09-01
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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)

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
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

Name	Time	Method
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.
Volume of distribution (Vz)	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.
Incidence of antidrug antibodies (ADA) at specified timepoints relative to baseline	up to Day113	To determine the immunogenicity of 9MW3811.

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China