Clinical trial NCT06714825: Study of HS235 for Assessing the Pharmacokinetics, Safety, and Pharmacodynamics in Overweight/Obese Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Overweight and Obesity
Lead sponsor: 35Pharma Inc
Sponsor class: INDUSTRY
First posted: 2024-12-04
Enrollment: 64
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: Study of HS235 for Assessing the Pharmacokinetics, Safety, and Pharmacodynamics of HS235 in Overweight and Obese Otherwise Healthy Subjects

Detailed description: A Phase 1 Study Assessing the Pharmacokinetics, Safety, and Pharmacodynamics of HS235 in Overweight and Obese Otherwise Healthy Subjects: Single Ascending Dose (SAD) in Males and Postmenopausal Females and Multiple Ascending Dose (MAD) in Males and Females of Non-childbearing Potential

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.

Primary outcomes:
measure: Incidence and Number of Adverse Events (AEs)
timeFrame: up to 106 days for Single dose and 147 days for multiple doses
Secondary outcomes:
measure: Area under concentration time curve (AUC) zero to t
timeFrame: up to 106 days for Single dose and 147 days for multiple doses
measure: Area under concentration time curve (AUC) zero-infinity
timeFrame: up to 106 days for Single dose and 147 days for multiple doses
measure: Maximum observed Plasma Concentration (Cmax)
timeFrame: up to 106 days for Single dose and 147 days for multiple doses
measure: Time to maximum concentration (Tmax)
timeFrame: up to 106 days for Single dose and 147 days for multiple doses
Other outcomes:
Locations:
city: Quebec city
country: Canada
facility: Syneos Clinical Research Unit
state: Quebec
Study officials:
affiliation: VP, Clinical Operations
name: Monique Champagne, M.Sc.
role: STUDY_DIRECTOR
References: