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

NCT04685564 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-04-26

No results posted yet for this study

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).

Conditions

  • Healthy Volunteers

Interventions

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

Sponsors & Collaborators

  • Suzhou Ribo Life Science Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Charlotte Dr. Lemech · Scientia Clinical Research Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-05
Primary Completion
2021-09-08
Completion
2021-11-02

Countries

  • Australia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04685564 on ClinicalTrials.gov