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

NCT05912049 | Unknown Phase 1

• 1 other identifier: 9MW3811-2023-CP103
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AEs) as assessed by CTCAE v5.0

  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.

  up to Day113

Secondary Outcomes (9)

• Maximum Plasma Concentration (Cmax)

  up to Day113

• Time to reach Cmax (Tmax)

  up to Day113

• Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)

  up to Day113

• Terminal elimination half-life (t1/2)

  up to Day113

• AUC from time 0 extrapolated to infinity (AUC0-inf)

  up to Day113

Study Arms (2)

9MW3811 Injection

EXPERIMENTAL

single dose escalation for experimental drug

Drug: 9MW3811 Injection

Placebo

PLACEBO COMPARATOR

matching placebo administration for control

Drug: Placebo

Interventions

9MW3811 Injection DRUG

Single dose intravenously infused on day 1

9MW3811 Injection

Placebo DRUG

Single dose of matching placebo intravenously infused on day 1

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female participants between 18 and 55 years of age, inclusive.
• 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.
• In good health determined by the investigator based on a medical evaluation.

You may not qualify if:

• Clinically significant histories determined by the investigator of cardiovascular, hepatic, renal, gastrointestinal, neurological, respiratory, hematological, endocrinological, immunological, metabolic, and musculoskeletal abnormalities.
• 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.
• 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)
• Participants who have been vaccinated within 4 weeks prior to screening or who are scheduled to be vaccinated during the study
• 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
• 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
• History of active tuberculosis, or participants with active or latent tuberculosis infection during screening
• 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)

Sponsors & Collaborators

• Mabwell (Shanghai) Bioscience Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215031, China

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: July 26, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 1, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)