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

NCT06714825 | Completed Phase 1 DMC

• 1 other identifier: HS235-001
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Area under concentration time curve (AUC) zero to t

  up to 106 days for Single dose and 147 days for multiple doses

• Area under concentration time curve (AUC) zero-infinity

  up to 106 days for Single dose and 147 days for multiple doses

• Maximum observed Plasma Concentration (Cmax)

  up to 106 days for Single dose and 147 days for multiple doses

• Time to maximum concentration (Tmax)

  up to 106 days for Single dose and 147 days for multiple doses

Study Arms (2)

Investigational Product

EXPERIMENTAL

HS235 Subcutaneous Injection

Biological: HS235

Placebo

PLACEBO COMPARATOR

Subcutaneous Injection

Drug: Placebo

Interventions

HS235 BIOLOGICAL

Up to 4 Single and 3 Multiple Ascending Doses

Investigational Product

Placebo DRUG

Subcutaneous Injection

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Females with a positive pregnancy test or who are lactating.
• Subjects with diabetes or have previous history of diabetes.
• Subjects who have recently donated blood, plasma and platelets.
• Subjects with history of alcoholism or drug abuse.
• 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.
• Subjects with clinically significant abnormal pulse or blood pressure or temperature.
• Subjects with a history of a clinically significant medical disorder or lab abnormality.
• Subjects with a significant history of multiple drug allergies, including infusion reactions and hypersensitivity to any of the excipients of HS235.
• 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.
• 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.
• Current or history of treatment with medications that may cause significant weight gain or loss, within 3 months or 5 half-lives of screening.
• Obesity induced by other endocrine disorders.
• Previous surgical treatment for obesity.
• Current or history of treatment with medications that may cause significant weight gain or loss.

Sponsors & Collaborators

• 35Pharma Inc: lead

Study Sites (1)

Syneos Clinical Research Unit

Québec, Quebec, Canada

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Monique Champagne, M.Sc.

  VP, Clinical Operations

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 4, 2024
• Study Start: November 28, 2024
• Primary Completion: December 2, 2025
• Study Completion: December 2, 2025
• Last Updated: December 30, 2025

Record last verified: 2024-12

Locations

CA (1)