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ACTIVE NOT RECRUITING
NCT05653037
PHASE1

A Single Ascending Doses Phase I Study to Evaluate the Safety and Pharmacokinetics of RBD4059 in Healthy Subjects

Sponsor: Suzhou Ribo Life Science Co. Ltd.

View on ClinicalTrials.gov

Summary

This is a Randomized, Single-blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of Subcutaneously Administered RBD4059 in Healthy Subjects. The study will be performed in single ascending dose (SAD) phase in healthy subjects. The decision to escalate to subsequent dose levels will be made by the SRC based on the review of all available safety information and PK/PD data in each cohort. RBD4059, a GalNAc conjugated siRNA, is an FXI-targeted new molecular entity independently developed by Ribo using its proprietary siRNA delivery system - RIBO-GalSTARTM.

Official title: A Randomized, Single-blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of Subcutaneously Administered RBD4059 in Healthy Subjects

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2023-03-21

Completion Date

2025-12

Last Updated

2024-12-03

Healthy Volunteers

Yes

Interventions

DRUG

RBD4059

Subcutaneously Administered RBD4059 in Healthy Subjects.

DRUG

Placebo

Subcutaneously Administered Placebo in Healthys Subject.

Locations (1)

Q-Pharm Pty Limited

Brisbane, Australia