NCT04220073

Phase I Study of Comparing Single Dose JS005 (Recombinant Humanized Monoclonal Antibody Against IL-17A) With Placebo in Tolerability, Safety, Immunogenicity and Pharmacokinetic in Healthy Volunteers

Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Tolerability, Safety, Immunogenicity and Pharmacokinetic Profile of Single Dose of JS005 (Recombinant Humanized Monoclonal Antibody Against IL-17A) Injection in Healthy Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

JS005-001 is one randomized, double-blind, placebo-controlled study to evaluate the tolerability, safety, immunogenicity and pharmacokinetic profile of single dose of JS005 injection in healthy volunteers. A total of 5 dose groups are set in the study, i.e., 15 mg, 60 mg, 150 mg, 300 mg and 600 mg, single dose will be given subcutaneously in abdomen. A total of 40 subjects are planned to be enrolled, 8 subjects will be enrolled in each group. Each dose group will be given the study drug and placebo at a ratio of 3:1. Each subject can only receive one single dose at one dose level. Sentinel method will be used for dose escalation, and one independent safety evaluation team (SET) will be set up. 2 subjects (one receiving study drug, the other receiving placebo) will be randomized preferably and followed up until 3 days after administration when the dose starts in each dose group, the remaining 6 subjects (5 receiving study drug, 1 receiving placebo) can continue to be randomized after confirmation with the sponsor, if no any dose-limiting event (DLE) is observed during that period. Only when all the subjects at present dose level complete the follow-up for at least 14 days after administration, and no dose-limiting event (DLE) is observed in any one subject, the next dose level can be initiated after confirmation with the independent safety evaluation team and the sponsor, otherwise they must be observed for the full term of follow-up (i.e., on Day 85). If DLE is observed throughout the observational period, it is confirmed that ≤2/6 subjects have DLE after administration of the study drug through unblinding by the independent safety evaluation team, the next dose level can be initiated; if \>2/6 subjects have DLE, the dose escalation will be terminated. The previous dose before that dose will be regarded as the maximum tolerated dose (MTD). When the dose for single dose is escalated to the preset maximum dose, and no safety endpoint is observed, it can be considered to continue to explore higher dose after joint decision by investigators and the sponsor.

Conditions

• Tolerability, Safety, Immunogenicity and Pharmacokinetic of JS005

Interventions

Type	Name	Description
BIOLOGICAL	JS005 (recombinant humanized monoclonal antibody against IL-17A)	JS005
DRUG	placebo	placebo

Timeline

• Start date: 2020-01-05
• Primary completion: 2020-09-21
• Completion: 2021-01-17
• First posted: 2020-01-07
• Last updated: 2020-01-07

Locations

1 site across 1 country: China