NCT05539651

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

A Randomized, Double-Blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of Subcutaneously Administered RBD5044 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Suzhou Ribo Life Science Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Health Volunteer

Interventions

Type	Name	Description
DRUG	RBD5044	Subcutaneously Administered RBD5044 in Healthy Subjects
DRUG	Placebo	Subcutaneously Administered Placebo in Healthy Subjects

Timeline

• Start date: 2022-11-10
• Primary completion: 2024-10-30
• Completion: 2024-10-30
• First posted: 2022-09-14
• Last updated: 2024-12-04

Locations

1 site across 1 country: Australia