A Comparative Study of the Pharmacokinetics of SIM0718 Injection in Healthy Adult Subjects in China

NCT06701149 | Not Yet Recruiting Phase 1

• 1 other identifier: SIM0718-101
• Study Type: interventional
• Target: 178
• Locations: 0 countries
• Sites: N/A

Brief Summary

A study to compare the pharmacokinetics, safety and immunogenicity of SIM0718 injection in healthy adult subjects in China

Conditions

Healthy Adult Subjects

Outcome Measures

Primary Outcomes (3)

• Primary pharmacokinetic (PK) parameters of SIM0718（Cmax）

  Primary pharmacokinetic (PK) parameters of a single subcutaneous administration of SIM0718 （Cmax）

  Day0-Day57

• Primary pharmacokinetic (PK) parameters of SIM0718（AUC0-t ）

  Primary pharmacokinetic (PK) parameters of a single subcutaneous administration of SIM0718 （AUC0-t ）

  Day0-Day57

• Primary pharmacokinetic (PK) parameters of SIM0718 （ AUC0-inf）

  Primary pharmacokinetic (PK) parameters of a single subcutaneous administration of SIM0718 （ AUC0-inf）

  Day0-Day57

Secondary Outcomes (23)

• Cmax of SIM0718 PK parameters

  Day0-Day57

• Adverse events of Safety of during the priod

  Day（-28）-Day57

• The positive rate and titer of anti-drug antibodies of immunogenicity

  Day0-Day57

• AUC0-inf of SIM0718 PK parameters

  Day0-Day57

• AUC0-t of SIM0718 PK parameters

  Day0-Day57

Study Arms (2)

Rademikibart injection

EXPERIMENTAL

Received subcutaneous injection administration on the morning of the first day .

Drug: Rademikibart injection

CBP-201 injection

ACTIVE COMPARATOR

Received subcutaneous injection administration on the morning of the first day.

Drug: CBP-201 injection

Interventions

Rademikibart injection DRUG

300 mg administered subcutaneously on the first day

Rademikibart injection

CBP-201 injection DRUG

300 mg administered subcutaneously on the first day

CBP-201 injection

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \) Able to read, understand, and voluntarily sign the informed consent form.
• \) Healthy adult male or female subjects aged 18\~50 years (including the cut-off value) at screening.
• \) The body mass index between 19 and 26 kg/m2 (including the cut-off value), and the weight of male subjects at least 50kg, and the weight of female subjects at least 45kg.
• \) Subjects (including male subjects) and their spouses/partners have no pregnancy plan (including sperm donation and egg donation) for at least 90 days after signing the informed consent form to the last dose and voluntarily take effective non-drug contraceptive measures.
• )5) Able to communicate well with clinical staff and complete the trial in accordance with the protocol requirements.

You may not qualify if:

• \) Subject has any clinically significant history of cardiovascular, respiratory (including asthma, bronchospasm), renal, hepatic, digestive, metabolic, endocrine, psychiatric, neurological, hematologic, or rheumatic disease, or has a psychiatric illness or disorder, or has a history of acute or chronic infections and other abnormalities that may affect safety or may affect the results of the study, as judged by the investigator.
• \) Patients with severe infection or systemic infection within 8 weeks before administration, requiring intravenous anti-infection treatment or hospitalization due to infection; Those who have an infection (including chronic or local infection) within 7 days before administration; Those with a history of recurrent infections and underlying diseases that are prone to infection; Those who currently suffer from oral herpes or shingles.
• \) Previous history of asthma, allergic reactions, allergic conjunctivitis, atopic dermatitis or other allergic diseases; History of significant allergy to any drug or previous serious adverse reaction to subcutaneous administration.
• \) Known symptoms of dermatitis or skin abnormalities in and around the site of administration. The proposed injection site has skin depression, skin induration, scarring, inflammation, edema, ulcer, infection, bleeding and any other conditions that are not suitable for subcutaneous injection.
• \) Those who have suffered from clinically significant major diseases or undergone major surgical operations within 1 month before dosing, or are expected to require major surgery during the trial.
• \) Active tuberculosis, latent tuberculosis, or history of nontuberculous mycobacterial infection at screening Note:
• Unless there is a clear specialist document, evidence that the disease has been adequately treated, and biologics are currently acceptable (in the medical judgment of the investigator and/or infectious disease specialist);
• T-spot testing may be used to aid in the diagnosis of people with suspected tuberculosis, if needed.
• \) Positive Treponema pallidum specific antibody (TP-Ab), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C antibody (HCV-Ab), human immunodeficiency virus antigen/antibody (HIV Ag/Ab).
• \) Abnormal vital signs at screening period or baseline as judged by the investigator to be clinically significant.
• \) During the screening period, the laboratory examination was judged to be clinically significant by the investigator.
• \) Female subjects who test positive for pregnancy during the screening period or baseline period or are lactating.
• \) The 12-lead ECG showed QTcF ≥450 ms for males or QTcF ≥470 ms for females at screening, or there were other clinically significant ECG abnormalities, which the investigator judged to be inappropriate to participate in the study.
• \) Use of prescription or over-the-counter drugs (including Chinese herbal medicines and health products) within 14 days or 5 half-lives (whichever is longer) before dosing.
• \) Use of IL-4 drugs before screening, or treatment with biologics within 12 weeks or 5 half-lives (whichever is longer) prior to dosing.

Sponsors & Collaborators

• Simcere Pharmaceutical Co., Ltd: lead

Study Officials

• wen qing

  Jinan Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

An gen qiang

CONTACT

+8602585566666; angenqiang@simcere.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2024
• First Posted: November 22, 2024
• Study Start: November 28, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 31, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-11