A First in Human Trial Evaluating THB335 in Healthy Participants

Launched by THIRD HARMONIC BIO, INC. · May 21, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new medication called THB335 in healthy adults to see how it affects the body. The study is divided into two parts: the first part looks at how a single dose of the drug works, and the second part examines the effects of taking multiple doses over time. It’s important to note that this trial is "double blind," meaning neither the participants nor the researchers know who is receiving the actual medication and who is getting a placebo (a dummy treatment). This helps ensure the results are unbiased.

To be eligible for this trial, participants should be healthy adults aged between 18 and 65, with a body weight of at least 50 kg for men and 45 kg for women. They must not have any significant health issues or be using any tobacco products. Participants will have to understand and agree to the study's procedures by signing a consent form. If you decide to join, you can expect some medical tests to ensure you meet the health criteria, and then you will receive either the study drug or a placebo while being monitored for safety and any side effects. This trial is currently recruiting participants, so if you're interested, it's a good time to learn more!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • In good health, determined by no clinically significant findings from medical history, 12 lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations
• • Males or females, of any race, between 18 and 65 years of age, inclusive.
• • Participants must understand the nature of the study and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study related procedures
• • Body weight of ≥ 50.0 kg for men and ≥ 45.0 kg for women and Body Mass Index (BMI) of 17.5-32.0 kg/m2 (inclusive) at Screening
• Exclusion Criteria:
• • Significant history or clinical manifestation of cancer or any metabolic, allergic, dermatological, hepatic, biliary, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
• • Vaccinated within 14 days prior to Day -1 or intention to receive vaccination during the study
• • A positive urine drug screen/alcohol breath test
• • The participant currently smokes, vapes, or uses nicotine-containing products.