NCT05167279

A Study of JS026 and JS026 Together With JS016 for Treatment of COVID-19

A Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetic Profiles, and Immunogenicity of JS026 and JS026 in Together With JS016 Administered Intravenously to Healthy Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a first-in-human (FIH), randomized, double-blind, placebo-controlled, single-center phase I clinical trial of JS026 and JS026 + JS016 Injection. The objective of the study is to evaluate the safety, tolerability, PK profile and immunogenicity of a single intravenous infusion of JS026 and JS026 + JS016 Injection in healthy subjects. In this study, the single ascending dose design will be adopted, JS026 will be administered sequentially from low dose group to high dose group, and each subject can only receive an intravenous infusion at one dose level. Five dose groups (30 mg, 100 mg, 300 mg, 600 mg, and 1000 mg) will be set to receive an intravenous infusion of JS026, and two dose groups (300 mg JS026 + 1200 mg JS016, and 600 mg JS026+ 1200 mg JS016) will be set for JS026 + JS016. The investigational product and placebo will be distributed in each dose group in a ratio of 3:1. Four subjects will be enrolled in each of JS026 30 mg and 100 mg groups, and 8 subjects will be enrolled in each of other dose groups, totally 48 subjects.

Detailed description

The entire trial period consists of a screening period of up to 14 days, a single dosing day (D1), and a 12-week follow-up period (84 days after dosing). Subjects will be admitted to the phase I clinical trial ward on the day before administration (D-1), and discharged after all examinations and assessments are completed on D4 after administration. Moreover, they will return to thestudy site for follow-up visits and relevant procedures and assessments as scheduled in the protocol.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	JS026/placebo	Five dose groups (30 mg, 100 mg, 300 mg, 600 mg, and 1000 mg) will be set to receive an intravenous infusion of JS026/placebo on Day1, and two dose groups (300 mg JS026 + 1200 mg JS016, and 600 mg JS026+ 1200 mg JS016) will be set to receive an intravenous infusion of JS026/placebo + JS016/placebo on Day1. The investigational product and placebo will be distributed in each dose group in a ratio of 3:1.
BIOLOGICAL	JS016/placebo	Two dose groups (300 mg + 1200 mg, and 600 mg + 1200 mg) will be set to receive an intravenous infusion of JS026/placebo + JS016/placebo on Day1. The investigational product and placebo will be distributed in each dose group in a ratio of 3:1.

Timeline

• Start date: 2021-12-16
• Primary completion: 2022-12-08
• Completion: 2022-12-08
• First posted: 2021-12-22
• Last updated: 2023-08-01

Locations

1 site across 1 country: China