NCT07030790

A Phase I Clinical Study of a Single Dose of KLA480

A Single-center, Randomized, Double-blind, Placebo-Controlled, Dose Escalation, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of a Single Subcutaneous Injection of KLA480 Injection in Healthy Chinese Participants

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Primary purpose: To evaluate the safety and tolerability of KLA480 injection after a single subcutaneous injection in healthy participants. Secondary purpose: To evaluate the pharmacokinetic (PK) characteristics of KLA480 injection after a single subcutaneous injection in healthy participants.

Detailed description

This study was a single-center, randomized, double-blind, placebo-controlled, dose Escalation, phase I clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of KLA480 injection after a single subcutaneous injection in healthy Chinese participants. The plan is to enroll 20 healthy participants in two dose groups: Group I (11.3 mg) and Group II (22.6 mg). Each dose group will includ 10 participants (at least 3 single-sex participants). Among them, 8 participants received the experimental drug KLA480 injection, and 2 participants received the placebo KLA480 injection simulator. Participants in different dose groups were successively enrolled. Based on the evaluation of acceptable tolerance and safety of participants in the former dose group, the researchers will discuss with the sponsor whether to carry out the next dose group. The "sentinel" method was used in each dose group, that is, 3 participants were enrolled in each dose group first, of which 2 participants received KLA480 injection, and 1 participant received placebo KLA480 injection simulator. Tolerance assessment will be performed 48 h after administration of the first 3 participants, and if the tolerance evaluation is acceptable, the remaining 7 participants in the current dose group will be enrolled (6 receiving the experimental drug and 1 receiving placebo).

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	KLA480 injection	Subcutaneous injection，Single dose
DRUG	Placebo	Subcutaneous injection，Single dose

Timeline

• Start date: 2025-05-17
• Primary completion: 2026-12-31
• Completion: 2027-03-01
• First posted: 2025-06-22
• Last updated: 2025-06-22

Locations

1 site across 1 country: China