Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, 250014, China
NCT Number: NCT05147259
The objective of the study is to assess the safety, tolerability and pharmacokinetics of HR011408 at two formulations in healthy subject.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Jinan, Shandong, 250014, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drug: HR011408 injection (formulation A), administered subcutaneously. Drug: HR011408 injection (formulation B), administered subcutaneously.
Time frame: from Day1 to Day15
The incidence of adverse events will be collected and the safety of HR011408 will be assessed
Time frame: from 0 to 10 hours after dose administration
Area under the concentration-time curve (AUC)
Time frame: from 0 to 10 hours after dose administration
Maximum observed concentration (Cmax)
Time frame: from 0 to 10 hours after dose administration
Time to maximum observed concentration (Tmax)
Time frame: from 0 to 10 hours after dose administration
Elimination half-life (t1/2)
Time frame: from 0 to 10 hours after dose administration
Time to 50% maximum observed concentration (time to 50% Cmax)
Time frame: from 0 to 10 hours after dose administration
First time point after dose administration when concentration reaches lower limit of quantification (LLOQ)
Time frame: from Day1 to Day15 after dose administration
Incidence of Anti-drug Antibodies (ADAs) will be assessed
Jiangsu HengRui Medicine Co., Ltd.
Industry
A Single Center, Randomized, Double-Blind, Single Ascending Dose, Crossover Designed Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HR011408 at Two Formulations in Healthy Subject
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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