Phase I of XKH001Injection in Healthy Adults

Healthy Adults Clinical Trial

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase I Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of XKH001Injection in Healthy Adults

Status Active, not recruiting

Clinical Trial Summary

XKH001is a recombinant humanized monoclonal IgG1 antibody for subcutaneous injection. XKH001 specifically blocks interleukin-25 from binding to its receptors.

To evaluate the safety, tolerability, pharmacokinetics (PK) of single ascending doses of XKH001 injection following subcutaneous administration

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled, phase 1 single ascending dose study to evaluate the safety, tolerability and pharmacokinetic characteristics of XKH001 in approximately 35 adult healthy volunteers.

The study will consist of a Screening Period (up to 21 days), an in-house Treatment Period, and a follow-up period.

Eligible subjects who signed the informed consent form (ICF) will be sequentially enrolled into one of the 5 dose cohorts: 0.5, 1.67, 3.34, 5.0 and 10.0 mg/kg. Three subjects will be enrolled in 0.5 mg/kg cohort (Cohort 1). All subjects in Cohort 1 will receive open-label XKH001. One sentinel participant will be dosed 48 hours prior to dosing the remainders of cohort 1. Eight subjects will be enrolled in the remaining dose cohorts (Cohort 2-5) and randomized to XKH001 or placebo after baseline evaluations are completed. Subjects will be admitted to the clinical research center the day before the administration of study drug (Day -1) For the study treatment of Cohort 2-5, the Investigator and other clinical center staff will be blinded. Any off-site staff who are unblinded will have no contact with the study participants. Two sentinel participants (randomized in a 1:1 ratio) will be dosed 48 hours prior to dosing the remainders of Cohort 2-5 (n=6, randomized in a 5:1 ratio). Subjects will be given a single dose of XKH001 or placebo (Cohort 2-5) on Day 1. After dosing, all subjects will be followed as inpatients through day 4. After discharge, all subjects will be followed for safety for 8 weeks and required to return to the clinical center for safety visits at the time points specified in Table 2.

A safety monitoring committee (SMC) will evaluate all available safety, and tolerability data within the first 21 days after the administration of the study drug. Escalation to the next higher dose level will stop if any of the stopping criteria defined in Section 7.1.2 is met. All subjects will have cleared the 21-day observation period at any given dose level before subjects are allowed to enroll at the next higher dose level. The dose level may be modified based on the emerging safety and PK data from this study via submission of a protocol amendment. ;

Related Conditions & MeSH terms

• Healthy Adults

• NCT number: NCT05128409
• Study type: Interventional
• Source: Suzhou Kanova Biopharmaceutical Co., LTD
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 7, 2023
• Completion date: December 1, 2024