Tolerability, Safety, Immunogenicity and Pharmacokinetic of JS005 Clinical Trial
Official title:
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
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.
n/a