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A Trial of CRB4101 in Healthy Subjects

NCT05641181 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-12-07

No results posted yet for this study

Summary

The goal of this clinical trial is toevaluate the safety and tolerability of a single dose of CRB4101 tablets in healthy adults . The main questions it aims to answer are:

* \[question 1\]The pharmacokinetics (PK) and pharmacodynamic dynamics (PD) characteristics of CRB4101 tablets were evaluated in healthy adults after a single administration.
* \[question 2\]Exploratory analysis of the relationship between serum concentrations of CRB4101 (and its major metabolites, if necessary) and QTc interphase.
* \[question 3\]Exploratory analysis of the metabolic and excretory characteristics of CRB4101 after a single administration (if necessary)
* \[question 4\]Exploratory analysis of pharmacokinetic characteristics of major metabolites of CRB4101 (if necessary)
* \[question 5\]The influence of pharmacogenomics on pharmacokinetic characteristics (if necessary).

After the participants who signed the informed consent have been screened by the inclusion criteria, those who meet the inclusion criteria and those who do not meet the exclusion criteria will receive the following 6 dose groups in order from low to high:

100mg, 200 mg, 400 mg, 800 mg, 1200 mg, 1600 mg

Conditions

  • Healthy Adult Subjects

Interventions

DRUG

CRB4101

After the participants who signed the informed consent have been screened by the inclusion criteria, those who meet the inclusion criteria and those who do not meet the exclusion criteria will receive the following 6 dose groups in order from low to high: 100mg, 200 mg, 400 mg, 800 mg, 1200 mg, 1600 mg In each dose group, 8 participants will be enrolled to receive the drug, including 6 receiving CRB4101 tablets and 2 receiving placebo.

DRUG

Placebo

After the participants who signed the informed consent have been screened by the inclusion criteria, those who meet the inclusion criteria and those who do not meet the exclusion criteria will receive the following 6 dose groups in order from low to high: 100mg, 200 mg, 400 mg, 800 mg, 1200 mg, 1600 mg In each dose group, 8 participants will be enrolled to receive the drug, including 6 receiving CRB4101 tablets and 2 receiving placebo.

Sponsors & Collaborators

  • Peking University Third Hospital

    collaborator OTHER

  • China Resources Biopharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2022-11-16
Primary Completion
2023-04-05
Completion
2023-06-21

Countries

  • China

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 NCT05641181 on ClinicalTrials.gov