Study of HS235 for Assessing the Pharmacokinetics, Safety, and Pharmacodynamics in Overweight/Obese Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Drug: Placebo; Biological: HS235

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

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada
      • Syneos Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational Product; HS235 Subcutaneous Injection	Biological: HS235; Up to 4 Single and 3 Multiple Ascending Doses
Placebo Comparator: Placebo; Subcutaneous Injection	Drug: Placebo; Subcutaneous Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and Number of Adverse Events (AEs)	An AE is any untoward medical occurrence in a patient or clinical trial patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.The incidence and number of patients who experience an AE will be reported.	up to 106 days for Single dose and 147 days for multiple doses

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under concentration time curve (AUC) zero to t	Blood samples will be collected to determine the Area under the concentration-time curve from time zero until the last observed concentration	up to 106 days for Single dose and 147 days for multiple doses
Area under concentration time curve (AUC) zero-infinity	Blood samples will be collected to determine the Area under the concentration-time curve from time zero to infinity (extrapolated)	up to 106 days for Single dose and 147 days for multiple doses
Maximum observed Plasma Concentration (Cmax)	Blood samples will be collected to determine Cmax	up to 106 days for Single dose and 147 days for multiple doses
Time to maximum concentration (Tmax)	Blood samples will be collected to determine Tmax	up to 106 days for Single dose and 147 days for multiple doses

Collaborators and Investigators

• Sponsor: 35Pharma Inc
• Investigators: Study Director: Monique Champagne, M.Sc., VP, Clinical Operations

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2024
• Primary Completion (Actual): December 2, 2025
• Study Completion (Actual): December 2, 2025

Study Registration Dates

• First Submitted: November 27, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: HS235-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No