A Phase 1 interventional study of QLM3003 and QLM3003 Placebo in Atopic Dermatitis, sponsored by Qilu Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment
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.
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.
1,443 studies on the registry are indexed under Dermatitis, Atopic; 253 are open to participants now.
This study's enrollment of 40 is below the median of 83 across 1,143 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Qilu Pharmaceutical Co., Ltd. is the lead sponsor of 195 studies on the registry; 117 are open to participants now.
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Exclusion Criteria:
QLM3003 Single dose
Drug: QLM3003
QLM3003 vehicle Single dose
Drug: QLM3003 Placebo
1%(10g∶0.1g)or 1.5%(10g∶0.15g)or 2%(10g∶0.2g)
1%(10g∶0.1g)or 1.5%(10g∶0.15g)or 2%(10g∶0.2g)(matching corresponding study medication)
Incidence (severity and causality) of any local and systemic adverse events
adverse events
Time frame: 8 days
Maximum Plasma Concentration (Cmax) of QLM3003
Cmax
Time frame: 8 days
Area Under the Plasma Concentration-Time Curve From 0 to t of QLM3003
AUC0-t
Time frame: 8 days
Area Under the Plasma Concentration-Time Curve From 0 to infinity of QLM3003
AUC0-∞
Time frame: 8 days
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Qilu Pharmaceutical Co., Ltd. →