NCT05932888

Safety, Tolerability, and Pharmacokinetic Study of QLM3003 in Healthy Adult Subjects

A Single Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of QLM3003 in Healthy Adult Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) doses of QLM3003 compared to placebo. Also, pharmacokinetics (PK) of qlm3003 will be evaluated.

Detailed description

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) doses of QLM3003 compared to placebo. Also, pharmacokinetics (PK) of qlm3003 will be evaluated.Eligible subjects will be assigned to a sequential treatment cohort and randomized to each treatment group (active/placebo ). Subject enrollment will continue into the next cohort after review of the dose safety from the previous dose cohort.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	QLM3003	1%（10g∶0.1g）or 1.5%（10g∶0.15g）or 2%（10g∶0.2g）
DRUG	QLM3003 Placebo	1%（10g∶0.1g）or 1.5%（10g∶0.15g）or 2%（10g∶0.2g）(matching corresponding study medication)

Timeline

• Start date: 2023-06-25
• Primary completion: 2023-08-05
• Completion: 2023-08-30
• First posted: 2023-07-06
• Last updated: 2023-09-21

Locations

1 site across 1 country: China