NCT04629287

Safety,Tolerability, and Pharmacokinetic of KPCXM18 for Injection

A Randomized, Blind, Placebo-controlled,Single Andmultiple Ascending Dose Study to Assess the Safety,Tolerability, and Pharmacokinetic of KPCXM18 for Injection in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Kunming Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

to assess the safety,Tolerability, and pharmacokinetic of KPCXM18 for injection in healthy subjects

Detailed description

To explore the safety, tolerance and pharmacokinetic of KPCXM18 for injection in healthy subjects by intravenous administration of different doses in single and multiple administration safety, tolerance and pharmacokinetic tests, and to obtain the safe dose range of the test drugs, thus providing dose design basis for phase II clinical trials.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	KPCXM18	KPCXM18,blind,freeze-dried powder,ascending doses，Intravenous route
DRUG	Placebo	Placebo,blind,freeze-dried powder,ascending doses，Intravenous route

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-12-01
• Completion: 2022-02-01
• First posted: 2020-11-16
• Last updated: 2020-11-19