JX09 SAD/MAD in Healthy Participants

Launched by JI XING PHARMACEUTICALS AUSTRALIA PTY LTD · Dec 14, 2023

Keywords

ClinConnect Summary

This clinical trial, called JX09 SAD/MAD in Healthy Participants, is studying a new treatment named JX09 to see how safe it is and how the body handles it. The trial is focused on individuals with resistant hypertension, a condition where blood pressure remains high even with treatment. This study is in its early phase and involves healthy adults between the ages of 18 and 55 who meet specific health criteria. Participants will be randomly assigned to receive either the study drug or a placebo (a look-alike pill with no active ingredients), and neither the participants nor the researchers will know who is receiving which.

To be eligible for the trial, participants must be in good health, with a body mass index (BMI) between 18 and 32 and a minimum weight of 50 kg. Those with certain medical conditions or who are pregnant or planning to become pregnant cannot participate. If you join the study, you can expect to undergo medical evaluations, including physical exams and lab tests, to ensure your safety. The trial is currently recruiting participants, and it provides a way to contribute to research that could help others with high blood pressure in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female aged 18 to 55 years (inclusive)
• • In good health as deemed by the Investigator through a medical evaluation, including medical history, physical examination, and laboratory tests
• • Body mass index (BMI) between 18 and 32 kg/m2, with a minimum weight of 50 kg at Screening
• Exclusion Criteria:
• • Clinically significant oncologic, infectious, cardiovascular, pulmonary, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, immunologic, renal, psychiatric, or other condition that in the opinion of the Investigator or Medical Monitor would make is unsafe for the participant to join the study or fulfill its requirements.
• • A clinical abnormality or abnormal laboratory parameter(s) in the opinion of the Investigator or Medical Monitor is likely to introduce additional risk or will affect data interpretation.
• • Postural tachycardia or hypotension.
• • Female of childbearing potential who is pregnant, lactating, or planning to become pregnant.