Assessing HS235 in overweight and obese healthy individuals

Phase 1 Single and Multiple Ascending Dose Study in Males and Females Assessing the Pharmacokinetics, Safety, and Pharmacodynamics of HS235 in Overweight and Obese Otherwise Healthy Subjects

This study is testing a new drug called HS235 in overweight and obese healthy adults to see how their bodies process it and if it’s safe.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: 35Pharma Inc (industry)
• Locations: 1 site (Quebec city, Quebec)
• Trial ID: NCT06714825 on ClinicalTrials.gov

What this trial studies

This Phase 1 study evaluates the pharmacokinetics, safety, and pharmacodynamics of HS235 in overweight and obese otherwise healthy subjects. It involves a single ascending dose (SAD) for males and postmenopausal females, followed by multiple ascending doses (MAD) for both males and females of non-childbearing potential. The study aims to gather data on how the drug is processed in the body and its effects on this specific population.

Who should consider this trial

Good fit: Ideal candidates are males and postmenopausal females aged 40 and above with a BMI between 28 and 40 kg/m2.

Not a fit: Patients with diabetes or a history of diabetes will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatment options for managing overweight and obesity.

How similar studies have performed: Other studies assessing pharmacokinetics and safety in similar populations have shown promise, but this specific approach with HS235 is novel.

Eligibility criteria

Inclusion Criteria:

1. Male or female above 40 years of age, inclusive.
2. Body Mass Index (BMI) between 28 and 40 kg/m2, inclusive.
3. Body weight at or below 140 kg with a stable body weight.
4. In good health or with no clinically significant medical conditions
5. Females who are post-menopausal or are of Non-child bearing Potential.
6. Male subjects must be willing not to donate sperm for 90 days after the last dose.
7. Able to understand the study procedures and provide signed informed consent to participate in the study.

Exclusion Criteria:

1. Females with a positive pregnancy test or who are lactating.
2. Subjects with diabetes or have previous history of diabetes.
3. Subjects who have recently donated blood, plasma and platelets.
4. Subjects with history of alcoholism or drug abuse.
5. Subjects who received systemic or topical medications, depot injections or implants, hormone replacement, non-prescribed medication or herbal remedies, or daily glucocorticoids for \> 1 month in previous year.
6. Subjects with clinically significant abnormal pulse or blood pressure or temperature.
7. Subjects with a history of a clinically significant medical disorder or lab abnormality.
8. Subjects with a significant history of multiple drug allergies, including infusion reactions and hypersensitivity to any of the excipients of HS235.
9. Subjects who are carriers of the hepatitis B surface antigen (HBsAg) and are carriers of the hepatitis C antibody (except if Polymerase Chain Reaction Ribonucleic acid (PCR RNA) is negative); or have a positive result to the test for human immunodeficiency virus (HIV) antigen or antibody.
10. Subjects who have, in the opinion of the Investigator, an abnormality in the echocardiogram or 12-lead ECG that put them at increased risk during the study.
11. Current or history of treatment with medications that may cause significant weight gain or loss, within 3 months or 5 half-lives of screening.
12. Obesity induced by other endocrine disorders.
13. Previous surgical treatment for obesity.
14. Current or history of treatment with medications that may cause significant weight gain or loss.

Where this trial is running

Quebec city, Quebec

• Syneos Clinical Research Unit — Quebec city, Quebec, Canada (RECRUITING)

Study contacts

• Study coordinator: Sarya Aziz, Ph.D.

Conditions: Overweight and Obesity