A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of Single- and Multiple-Ascending Doses of MH-001 in Healthy Volunteers

Launched by VESPINA LIFESCIENCES INC. · Jan 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called MH-001 to see how it behaves in the body and how safe it is for healthy individuals. The focus is on testing different doses to figure out the best and safest amounts to use. The trial is currently looking for healthy volunteers aged between 18 and 55, who do not smoke and meet certain health criteria. For example, participants should have a normal body weight and no significant health issues related to their heart, lungs, or other major systems.

If you decide to join this study, you can expect to receive either a single dose or multiple doses of the medication while being closely monitored by healthcare professionals. This means they will keep track of your health and any side effects to ensure your safety throughout the trial. It's important to note that individuals with certain medical conditions, such as serious heart or kidney problems, or those with a history of skin diseases, will not be able to participate. This study is a crucial first step in understanding how MH-001 might be used in future treatments, so your involvement could help advance medical research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or non-childbearing potential Female, non smoker, with a Body Mass Index (BMI) between 18.5 and 32.0 kilogram per meter square (kg/m2) and red blood cells greater or equal (≥) to 120 grams per liter (g/L) for women and ≥135 g/L for men
• • In good health, determined by no clinically significant findings of skin, dental, neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease
• Exclusion Criteria:
• • Have a history or presence of clinically significant medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, chronic or relevant acute infections, relevant immunodeficiency, renal, endocrine, psychiatric or neurological disease, or any clinically significant laboratory abnormality that, in the judgment of the Investigator, indicates a medical problem that would preclude study participation.
• • History of skin disorders including clinically significant active skin disease.
• • History/signs and symptoms of current or recurrent teeth and gums disease
• • Clinically significant abnormal laboratory test results or positive hepatitis panel and/or positive human immunodeficiency virus test.