Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection

NCT05027373 | Unknown Phase 1

• 1 other identifier: SSGJ-613-HH-I-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This study is Safety, Tolerability and Pharmacokinetic of Recombinant anti-IL-1β Humanized Monoclonal Antibody injection in Healthy Subjects. Pharmacokinetics, Pharmacodynamics and Anti-drug antibody (ADA) data will be collected; Drug safety, tolerability and immunogenicity for healthy subjects will be evaluated.

Conditions

Systemic Juvenile Idiopathic Arthritis; Periodic Fever Syndrome

Outcome Measures

Primary Outcomes (10)

• Cmax

  up to 112 days

• Tmax

  up to 112 days

• AUC0-t

  up to 112 days

• t1/2

  up to 112 days

• CL/F

  up to 112 days

• Vd/F

  up to 112 days

• Ke

  up to 112 days

• AUC0-∞

  up to 112 days

• AE

  up to 112 days

• SAE

  up to 112 days

Secondary Outcomes (3)

• total IL-1β

  up to 112 days

• free IL-1β

  up to 112 days

• ADA

  up to 112 days

Study Arms (2)

SSGJ-613

EXPERIMENTAL

Drug: SSGJ-613

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SSGJ-613 DRUG

SSGJ-613 injection is 200mg/2mL solution in a single vial.The solution is a clear to slightly opalescent, colorless to a slightly yellow tint.

SSGJ-613

Placebo DRUG

Placebo injection is 2mL excipient solution in a single vial.The solution is clear and colorless.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese healthy participants, male or female, aged 18 to 45 (including both ends)
• The body mass index (BMI) is in the range of 19.0\~28.0 kg•m-2 (including both ends), and the weight of men is generally not less than 50kg, while the women is generally not less than 45kg
• Male participants and their partners or female participants must agree to take one or more non-drug contraceptives (such as complete abstinence, contraceptive rings, partner ligation, etc.) , and there is no sperm donation or egg donation plan until 3 months after finished the study
• Participants should fully understand the purpose, nature, methods and possible adverse reactions of the trial, volunteer to participate in the trial and sign the informed consent
• Participants could communicate well with the researchers and compliance with the trial

You may not qualify if:

• Those who are allergic to the study drug and any of its excipients. Subjects who have a history of allergy to monoclonal antibodies
• Subjects who have or are currently suffering from any serious clinical diseases 3-6 months before screening, such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities or any other that can interfere with the study results
• Clinical laboratory examinations (blood routine, urine routine, blood biochemistry, coagulation function, etc.), auxiliary examinations (chest X-ray, abdominal ultrasound) found to be abnormal and have clinical significance
• Positive for Hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HbcAb), anti- Hepatitis C virus antibodies (HCV), or anti-human immunodeficiency virus (HIV)
• Alcoholics or frequent drinkers within 3 months before the trial, drinking more than 14 units per week (1 unit alcohol ≈360 mL beer or 45 mL spirits or 150 mL wine), or those who have a positive alcohol breath test (screening period or baseline period) or couldn't prohibit alcohol during the trial
• Those who smoked more than 5 cigarettes per day during the 3 months before screening, or have a positive urine nicotine screening test (screening period or baseline period)
• Drug abusers or those who have used soft drugs (such as marijuana) within 3 months or took hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the trial, or have positive drug abuse screening (morphine, Ketamine, tetrahydrocannabinol acid, methamphetamine , dimethyldioxyamphetamine, cocaine)
• Has taken any prescription medicine, non-prescription medicine, Chinese patent medicine within 14 days before administration
• Has received any monoclonal antibody drugs within 3 months before administration
• Has a history of vaccination within 3 months before dosing, or intend to receive vaccines during the study
• Was previously enrolled in other clinical trials within 3 months before dosing
• Blood donors or subjects who lost a lot of blood (\> 400 mL, except for women's physiological period) or those who received blood transfusion or used blood products within 3 months
• Can't tolerate venipuncture or has a history of halo needles and halo blood
• Has known or suspected pregnancy or lactation
• Abnormal vital signs (SBP \<90 mmHg or ≥140 mmHg, DBP \<55 mmHg or ≥90 mmHg; heart rate \<50 bpm or\> 100 bpm; body temperature \<35.4℃ or \> 37.3℃) or abnormal ECG (QTcF ≥450 ms) or physical examination are clinically significant (according to the judgment of clinical research doctors)

Sponsors & Collaborators

• Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.: lead

Study Sites (1)

Shanghai Xuhui District Central Hospital

Shanghai, Shanghai Municipality, 201203, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Qian Chen, PhD

CONTACT

02154030254; qchen@shxh-centerlab.com

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: August 17, 2021
• First Posted: August 30, 2021
• Study Start: August 13, 2021
• Primary Completion: April 30, 2022
• Study Completion: September 30, 2022
• Last Updated: August 30, 2021

Record last verified: 2021-08

Locations

CN (1)