NCT04685564

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Suzhou Ribo Life Science Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	RBD1016	"Sentinel cohort" design is used in each cohort: each cohort will be administered in two batches, the first 2 subjects will receive RBD1016 or placebo respectively, and safety assessment will be done on D8±1. After safety is confirmed through SRC assessment, the remaining 6 subjects will be randomly assigned to receive RBD1016 or placebo in a ratio of 5:1. SRC will assess the safety after all the subjects in each cohort complete the 28-day safety observation and the subjects may proceed to the next dose cohort with permission. Only after all the subjects in the previous dose cohort have completed the safety assessment by SRC (observed for 28 days) may the next dose cohort be initiated with permission.
DRUG	Placebo	the same as RBD1016

Timeline

• Start date: 2021-02-05
• Primary completion: 2021-09-08
• Completion: 2021-11-02
• First posted: 2020-12-28
• Last updated: 2022-04-26

Locations

1 site across 1 country: Australia