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A Single and Multiple Ascending Doses Study to Evaluate the Safety and Pharmacokinetics of RBD5044

NCT05539651 ↗

Phase 1 Completed 72 enrolled Suzhou Ribo Life Science Co. Ltd.
RandomizedSequentialQuadruple-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled phase I study to evaluate the safety, tolerability, PK profiles and PD effect of single and multiple ascending doses of subcutaneously administered RBD5044 in healthy subjects. The study will be performed in 2 phases: single ascending dose (SAD) phase and multiple ascending doses (MAD) phase in healthy subjects. There are 6 cohorts in SAD phases, the dose levels are 5mg, 20mg, 60mg, 90mg, 120mg and 150mg. There are 3 cohorts in MAD phases, the dose levels are 60mg, 90mg and 120mg.The decision to escalate to subsequent dose levels will be made by the SRC based on the review of all available safety information, including AEs, ECGs, vital signs, and clinical laboratory test results in each cohort.

Timeline

Start
2022-11-10
Primary completion
2024-10-30
Completion
2024-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject RBD5044 Unknown 5 mg Subcutaneous
Subject RBD5044 Unknown 20 mg Subcutaneous
Subject RBD5044 Unknown 60 mg Subcutaneous
Subject RBD5044 Unknown 90 mg Subcutaneous
Subject RBD5044 Unknown 120 mg Subcutaneous
Subject RBD5044 Unknown 150 mg Subcutaneous

Indications

No indication recorded.