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

Systemic Juvenile Idiopathic Arthritis Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Parallel Trial of Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-1β Humanized Monoclonal Antibody by Single Subcutaneous Injection in Healthy Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05027373
• Other study ID #: SSGJ-613-HH-I-01
• Status: Recruiting
• Phase: Phase 1
• Start date: August 13, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: August 2021
• Source: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
• Contact: Qian Chen, PhD
• Phone: 02154030254
• Email: qchen[@]shxh-centerlab.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study is a randomized, double-blind, placebo-controlled parallel trial of safety, tolerability and pharmacokinetic of Recombinant anti-IL-1β Humanized Monoclonal Antibody by single subcutaneous injection with five different doses in healthy subjects. There are 5 groups as follows: 0.03mg/kg (S1), 1.0mg/kg (S2), 3.0mg/kg (S3), 6.0mg/kg (S4) and 10.0mg/kg (S5); and 2 subjects were included in the S1 group (both received study drugs); 8 subjects were included in each of the S2 ~ S5 groups (of which 6 received study drugs and 2 received placebo). In each group, two subjects were sentinels (1 received the study drug and 1 placebo). Pharmacokinetics, Pharmacodynamics and Anti-drug antibody (ADA) data will be collected; Drug safety, tolerability and immunogenicity for healthy subjects will be evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: September 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

• Those who are infected and need to be treated for acute or chronic infections, as follows:

• Suffering from herpes zoster within 12 months before screening;

• Currently in any inhibitory treatment for chronic infections (eg, tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster virus, and atypical mycobacteria);

• A history of tuberculosis or contact with patients with open tuberculosis in the past 6 months,or a T-spoT-positive results;

• Infected with parasites within 3 months before administration;

• Hospitalized for infectious diseases within 30 days before administration;

• Received anti-infective drugs (including antibacterial, antiviral, antifungal, or antiparasitic drugs) by parenteral administration (iv or im) 30 days before administration

• Subjects who are unsuited to the study for any reason, judged by the investigators

Related Conditions & MeSH terms

• Arthritis, Juvenile
• Familial Mediterranean Fever
• Systemic Juvenile Idiopathic Arthritis

Intervention

Drug:
• SSGJ-613
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.
• Placebo
Placebo injection is 2mL excipient solution in a single vial.The solution is clear and colorless.

Locations

Country	Name	City	State
China	Shanghai Xuhui District Central Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax		up to 112 days
Primary	Tmax		up to 112 days
Primary	AUC0-t		up to 112 days
Primary	t1/2		up to 112 days
Primary	CL/F		up to 112 days
Primary	Vd/F		up to 112 days
Primary	Ke		up to 112 days
Primary	AUC0-8		up to 112 days
Primary	AE		up to 112 days
Primary	SAE		up to 112 days
Secondary	total IL-1ß		up to 112 days
Secondary	free IL-1ß		up to 112 days
Secondary	ADA	Bridging method will be used to detect the incidence and titer for ADA through one three-step detection strategy, that is preliminary screening, confirmation and titer	up to 112 days