To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIM0278 in Chinese Healthy Subjects

NCT06022354 | Completed Phase 1

• 1 other identifier: SIM0278-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, randomized, double-blind, placebo-controlled trial of SIM0278 in healthy subjects. The study will be conducted in 2 parts. Part 1 is single ascending dose study. Part 2 is multiple ascending dose study.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) of subcutaneous injections of SIM0278 in healthy subjects after single dose (Part 1) or multiple dose (Part 2) administration

  Part 1:up to 29 days after the first dose of treatment; Part 2:up to 85 days after the first dose of treatment

Secondary Outcomes (7)

• Peak plasma concentration(Cmax) of SIM0278 in serum

  Time Frame: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment

• Time to reach maximum concentration (Tmax) of SIM0278 in serum

  Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment

• Area under the curve (AUC) of SIM0278in serum

  Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment

• Half life (T1/2) of SIM0278 in serum

  Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment

• Total body clearance (CL/F) of SIM0278 in serum

  Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment

Other Outcomes (6)

• Fold Change from Baseline in Regulatory T cells (Tregs)

  Part 1: Pre-dose on Day1 up to 29 days after the first dose of treatment; Part 2: Pre-dose on Day1 up to 71 days after the first dose of treatment

• Fold Change from Baseline in Conventional CD4+ T Cells

  Part 1: Pre-dose on Day1 up to 29 days after the first dose of treatment; Part 2: Pre-dose on Day1 up to 71 days after the first dose of treatment

• Fold Change from Baseline in Conventional CD8+ T Cells

  Part 1: Pre-dose on Day1 up to 29 days after the first dose of treatment; Part 2: Pre-dose on Day1 up to 71 days after the first dose of treatment

Study Arms (11)

Part 1 : cohort 1: SIM0278 or placebo

EXPERIMENTAL

Drug: SIM0278 Injection/Placebo

Part 1 : cohort 2: SIM0278 or placebo

EXPERIMENTAL

Drug: SIM0278 Injection/Placebo

Part 1 : cohort 3: SIM0278 or placebo

EXPERIMENTAL

Drug: SIM0278 Injection/Placebo

Part 1 : cohort 4: SIM0278 or placebo

EXPERIMENTAL

Drug: SIM0278 Injection/Placebo

Part 1 : cohort 5: SIM0278 or placebo

EXPERIMENTAL

Drug: SIM0278 Injection/Placebo

Part 1 : cohort 6: SIM0278 or placebo

EXPERIMENTAL

Drug: SIM0278 Injection/Placebo

Part 1 : cohort 7: SIM0278 or placebo

EXPERIMENTAL

Drug: SIM0278 Injection/Placebo

Part 2 : cohort 1: SIM0278 or placebo

EXPERIMENTAL

Drug: SIM0278 Injection/Placebo

Part 2 : cohort 2: SIM0278 or placebo

EXPERIMENTAL

Drug: SIM0278 Injection/Placebo

Part 2 : cohort 3: SIM0278 or placebo

EXPERIMENTAL

Drug: SIM0278 Injection/Placebo

Part 2 : cohort 4: SIM0278 or placebo

EXPERIMENTAL

Drug: SIM0278 Injection/Placebo

Interventions

SIM0278 Injection/Placebo DRUG

SIM0278 Injection/Placebo

Part 1 : cohort 1: SIM0278 or placebo; Part 1 : cohort 2: SIM0278 or placebo; Part 1 : cohort 3: SIM0278 or placebo; Part 1 : cohort 4: SIM0278 or placebo; Part 1 : cohort 5: SIM0278 or placebo; Part 1 : cohort 6: SIM0278 or placebo; Part 1 : cohort 7: SIM0278 or placebo; Part 2 : cohort 1: SIM0278 or placebo; Part 2 : cohort 2: SIM0278 or placebo; Part 2 : cohort 3: SIM0278 or placebo; Part 2 : cohort 4: SIM0278 or placebo

Eligibility Criteria

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

You may qualify if:

• Subject must be 18 to 55 years of age (inclusive), at the time of signing the informed consent.
• Body Mass Index (BMI) ≥ 18 and ≤ 28 kg/m2 and weight at least 45 kg at screening.
• A condition of general good health, as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, vital signs, laboratory profile, a 12-lead electrocardiogram (ECG) and chest X-ray.
• A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
• Not a woman of childbearing potential (WOCBP) as defined in, OR
• A WOCBP who agrees to follow the contraceptive guidance in from screening through at least 90 days after the last dose of study drug; a WOCBP must have a negative beta-human chorionic gonadotropin (β-hCG) test at screening and baseline prior to administration of investigational product.
• A male subject must agree to use contraception as detailed in this protocol from screening through at least 90 days after the last dose of study drug. Sperm donation is also restricted during the time-frame that males must practice highly effective method of contraception. This criterion may be waived for male subjects who have had a vasectomy more than (\>) 90 days prior to screening.
• Must voluntarily sign and date each informed consent approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.

You may not qualify if:

• History of significant sensitivity to any drug or previous severe adverse reaction to subcutaneous medication.
• Subject has a history of any clinically significant cardiac, respiratory (including asthma, bronchospasm), renal, hepatic, gastrointestinal, psychiatric, neurologic, hematologic or rheumatic disease, or psychiatric disease or disorder, current acute or chronic infections, or other abnormality that may affect safety, or potentially influence the study results, judged by the investigator.
• Chronic or active infection(s) requiring treatment with intravenous anti-infectives within 4 weeks prior to the dose of study drug, or oral anti-infectives within 2 weeks prior to Day 1, or positive test for novel coronavirus antigen or nucleic acid within 4 weeks prior to first dose
• Evidence or history of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma.
• History of chronic or active hepatitis, or current positive result, including hepatitis B or hepatitis C infection, as evidenced by a positive test for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab).
• History of tuberculosis (TB), or active or latent TB on the basis of positive medical history.
• History of or positive screening test for human immunodeficiency virus (HIV) infection; any genetic, congenital, or acquired immunodeficiency syndrome, or any chronic recurring infections (including mucocutaneous candidiasis).
• Systolic blood pressure (BP) ≥ 140 mmHg or ≤ 90 mmHg, or diastolic BP≥ 90 mmHg or ≤50 mm Hg, or HR \> 100 bpm, at Screening or baseline，and abnormal clinically significant should be judged by the investigator
• Subjects with ANY of the following abnormalities in clinical laboratory tests at screening:
• Neutrophil or lymphocyte counts below the normal range; Eosinophil count above the normal range.
• Estimated glomerular filtration rate (GFR) by Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) calculation ≤90 mL/min/1.73 m2 at screening.
• Aspartate aminotransferase (AST)、Alanine transaminase (ALT) \>1.5 x upper limit of normal (ULN)
• Total bilirubin \>1.2 x ULN
• Other clinically significant abnormalities of laboratory assessments, as judged by the Investigator and/or sponsor Medical Monitor, that could affect the safety of the subject, or the interpretation of the data from the study.
• lead ECG demonstrating QTcF≥450 msec（male）or QTcF≥470 msec（female） at Screening. Subject who have II or III degree atrioventricular block or other clinically significant electrocardiogram abnormalitieshas, in the opinion of the investigator, are unsuitable subjects in the study.

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Affiliated Hospital of Qingdao University

Qingdao, China, Shandong, 266001, China

Location

Study Design

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

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: September 1, 2023
• Study Start: August 23, 2023
• Primary Completion: March 18, 2025
• Study Completion: July 22, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)