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

NCT ID: NCT06714825

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-28

Study Completion Date

2025-12-02

Brief Summary

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

Detailed Description

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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

Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Investigational Product

HS235 Subcutaneous Injection

Group Type EXPERIMENTAL

HS235

Intervention Type BIOLOGICAL

Up to 4 Single and 3 Multiple Ascending Doses

Placebo

Subcutaneous Injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subcutaneous Injection

Interventions

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HS235

Up to 4 Single and 3 Multiple Ascending Doses

Intervention Type BIOLOGICAL

Placebo

Subcutaneous Injection

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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35Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Monique Champagne, M.Sc.

Role: STUDY_DIRECTOR

VP, Clinical Operations

Locations

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Syneos Clinical Research Unit

Québec, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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HS235-001

Identifier Type: -

Identifier Source: org_study_id