NCT07474545

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KL0011034 Injection in Healthy Volunteers

A Single-center, Randomized, Double-blind, Placebo-Controlled,Positive-Controlled, Dose-Escalation, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of a Single Dose Injection of KL0011034 Injection in Healthy Chinese Volunteers

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Hunan Kelun Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single intravenous doses of KL0011034 injection in healthy volunteers.

Detailed description

This trial is a randomized, double-blind, placebo- and active-controlled, single-dose escalation study in healthy volunteers. A total of 76 volunteers will be enrolled. Healthy volunteers will be randomly assigned to receive KL0011034 injection, placebo, or Etomidate Injectable Emulsion. Each volunteer is allowed to participate in only one dose cohort; intra-volunteer dose escalation is not permitted. Enrollment into the next cohort will begin only after safety and tolerability data from the previous cohort have been reviewed and deemed acceptable by the investigator(s) and sponsor. If the highest dose is well tolerated, the investigator(s) and sponsor will evaluate the accumulated data and decide whether to terminate dose escalation or continue to higher dose levels.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	KL0011034 injection	Intravenous injection, single dose
DRUG	Placebo	Intravenous injection, single dose
DRUG	Etomidate Injectable Emulsion	Intravenous injection, single dose

Timeline

• Start date: 2026-03-07
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: China