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

NCT ID: NCT05912049

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-26
• Study Completion Date: 2023-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

9MW3811 Injection

single dose escalation for experimental drug

Group Type: EXPERIMENTAL

9MW3811 Injection

Intervention Type: DRUG

Single dose intravenously infused on day 1

Placebo

matching placebo administration for control

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single dose of matching placebo intravenously infused on day 1

Interventions

9MW3811 Injection

Single dose intravenously infused on day 1

Intervention Type: DRUG

Placebo

Single dose of matching placebo intravenously infused on day 1

Intervention Type: DRUG

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 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mabwell (Shanghai) Bioscience Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Liyan Miao, Professor

Role: primary

miaolysuzhou@163.com

0512-67972858

Other Identifiers

9MW3811-2023-CP103

Identifier Type: -

Identifier Source: org_study_id