A Single Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of RBD1016

Healthy Volunteers Clinical Trial

Official title: A Randomized, Double-blind, Placebo-controlled, Single Dose-escalation, Phase Ia Clinical Study to Evaluate the Safety and Pharmacokinetics of RBD1016 in Healthy Subjects

Status Completed

Clinical Trial Summary

This is a single dose-escalation phase Ⅰa clinical study to observe the safety and pharmacokinetic profiles of RBD1016 in healthy subjects.

The study consists of screening period (Day -28 to Day -1), treatment period (Day 1 to Day 2), safety assessment period (to Day 29) and safety follow-up period (up to Day 85).

Clinical Trial Description

It is a randomized, double-blind, placebo-controlled, single dose-escalation, phase Ia study. The study will enroll 40 healthy subjects, including 5 dose escalation cohorts for dose escalation with 0.3 mg/kg body weight as the starting dose.

After a single-dose injection, there will be a 4-week safety assessment and monitoring phase (Days 1-29). Blood samples for PK analysis will be collected within 60 minutes before dosing, and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after dosing, respectively. According to the previous PK results, the subsequent PK blood collection points can be adjusted. Total urine samples will be collected once before dosing and in each of 2 time periods after dosing: 0~8 h and 8~24 h. The total urine output will be recorded, and some urine samples will be collected in each time period to analyze and detect the urine drug concentration.

Subjects will undergo safety follow-up from Day 29 to Day 85. ;

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT04685564
• Study type: Interventional
• Source: Suzhou Ribo Life Science Co. Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: February 5, 2021
• Completion date: November 2, 2021