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Evaluation of the Safety, Tolerability and Pharmacokinetics of TUL108 for Injection in Healthy Participants (SAD/ MAD)
Sponsor: Zhuhai United Laboratories Co., Ltd.
Summary
To evaluate the safety, tolerability and pharmacokinetics of single and multiple intravenous (IV) infusion of TUL108 in healthy participants.
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of TUL108 for Injection After Single and Multiple Intravenous Infusions in Healthy Participants.
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2026-07-30
Completion Date
2026-12-30
Last Updated
2026-07-22
Healthy Volunteers
Yes
Interventions
TUL108
50 mg、125 mg、250 mg、500 mg、1000 mg、1500 mg
Placebo
0.9% Sodium Chloride Injection
TUL108
125 mg、250 mg、500 mg
Locations (1)
Huashan Hospital affiliated to Fudan University
Shanghai, China