NCT05027373

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Systemic Juvenile Idiopathic Arthritis
• Periodic Fever Syndrome

Interventions

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

Timeline

• Start date: 2021-08-13
• Primary completion: 2022-04-30
• Completion: 2022-09-30
• First posted: 2021-08-30
• Last updated: 2021-08-30

Locations

1 site across 1 country: China