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Ascending Single-Dose and Multiple-Dose Study to Evaluate RJ4287 in Healthy Subjects | Clinical Trials | Clareo Health

UNKNOWNPHASE1

Ascending Single-Dose and Multiple-Dose Study to Evaluate RJ4287 in Healthy Subjects

A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food-effect of Single and Multiple Oral Doses of RJ4287 in Healthy Volunteers

NCT05921006•Nanjing Ruijie Pharma Co., Ltd.

View on ClinicalTrials.gov

Summary

A Randomized Study of RJ4287 Drug to Evaluate the Safety, Tolerability, Pharmacokinetics and Food-effect of Single and Multiple Doses in Healthy Volunteers

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Male and Female between 18 and 55 years old，inclusive
•Body weight \>50 kg for Male and \>45 kg for Female with a body mass index BMI between 19-28 kg/m2（inclusive）
•Female subjects of childbearing potential who have had no unprotected sex within 14 days prior to screening and who have had a negative pregnancy test during the screening period; subjects (including partners) who have no plans for pregnancy, sperm donation or egg donation and are willing to use effective contraception from the time of informed consent until 6 months after administration of the test product;
•The subject must be willing and able to provide written informed consent

Exclusion Criteria

•History of thyroid disorder or abnormal thyroid function tests at screening
•Abnormal abdominal ultrasound findings with clinical significance
•Sensitivity to thyroid medication or history of sensitivity to a similar study drug(eg.MGL-3196)
•History of sensitivity to a similar study drug
•Major surgical procedure, previous gastrointestinal surgery, vagotomy, bowel resection or any surgical procedure that may interfere with peristalsis, pH or absorption in the gastrointestinal tract within 6 months prior to screening
•Subjects who, in the judgement of the investigator, have a condition that affects the absorption, distribution, metabolism and excretion of the drug (e.g. gastrointestinal dysfunction, peptic ulcer, gastrointestinal surgery, etc.) or who are unable to comply with a uniform diet during the trial
•Taken any prescription medication, over-the-counter medication, any vitamin product or herbal remedy within 1 month prior to screening
•Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results interpretation
•History of regular use nicotine or alcohol，unable to abstain from smoking and alcohol during the trial
•Previous blood donation or blood loss of more than 400 mL within 3 months prior to taking the study drug
+4 more criteria

Locations (1)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Key Dates

Start Date

June 13, 2023

Primary Completion Date

December 1, 2023

Completion Date

December 1, 2023

Last Updated

July 6, 2023

Enrollment

ESTIMATED participants

Conditions

Drug Safety

Interventions

RJ4287

DRUG

Placebo

DRUG

Contacts

Zhenning Li, MD

CONTACT

0086-025-52391708 znli@rjpharma.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Ascending Single-Dose and Multiple-Dose Study to Evaluate RJ4287 in Healthy Subjects

Inclusion Criteria

Exclusion Criteria

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