NCT06633055

A Phase I Clinical Trial of JH013 Injection

A Phase I Clinical Trial of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JH013 Injection in Healthy Subjects

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Biotech Pharmaceutical Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a phase I clinical trial with a single dose escalation to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of JH013 injection in healthy subjects

Detailed description

Four dose groups were set up, 75 mg, 150 mg, 300 mg, and 500 mg, respectively. Eight subjects (6 subjects received JH013 injection, 2 subjects received placebo) were planned to be included in each dose group for subcutaneous administration.The safety and tolerability within 48 hours after administration were first observed in each dose group with 2 subjects (1 subject receiving JH013 injection and 1 subject receiving placebo),after that, the remaining 6 subjects (5 receiving JH013 injection and 1 receiving placebo) were enrolled. Each subject may only participate in this trial in one dose group, and the next higher dose trial will only be allowed after it has been determined that the previous dose has been well safe and tolerated within 28 days of dosing (as determined by an independent, unblinded third-party physician in conjunction with the investigator and sponsor). When the safety evaluation meets the termination criteria during the dose escalation process, the dose between the dose group and the previous dose group can be returned if necessary after discussion by the investigator and the sponsor, and the maximum safe tolerated dose can be explored again. When the dose is escalated to the highest dose set by the protocol and the dose termination criteria are not met, it is up to the investigator and the sponsor to discuss whether to expand to a higher dose.

Conditions

• Healthy Subjects (HS)

Interventions

Type	Name	Description
DRUG	JH013 injection	JH013 injection is a BAFF-R inhibitor monoclonal antibody
DRUG	Placebo	JH013 injections placebo

Timeline

• Start date: 2024-10-31
• Primary completion: 2025-06-30
• Completion: 2025-12-31
• First posted: 2024-10-09
• Last updated: 2024-10-09