Clinical trial NCT06481098: A Phase 1 Study to Assess HM15275 in Healthy and Obese Subjects.
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15275 in Healthy and Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Keywords: Obesity
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2024-07-01
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Part A: single-ascending dose Part B: multiple-ascending dose
Primary purpose: TREATMENT

Brief summary: This Study is a Phase 1 Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15275 in Healthy and Obese Subjects.


Eligibility criteria: Inclusion Criteria:

1. Female and male adults, ages ≥ 18 and ≤ 65 years.
2. Part A: Healthy subjects with body mass index (BMI) ≥ 20.0 kg/m2 and ≤ 27 kg/m2.

   Part B: Obese subjects with BMI ≥ 30.0 kg/m2 and ≤ 45.0 kg/m2 with a stable body weight for 3 months prior to screening (defined as change \< 5%).
3. HbA1c \< 6.5 % \[based on American Diabetes Association, 2023\].
4. Female subjects must be non-pregnant and non-lactating.
5. Subjects must be able to provide written informed consent and are willing to follow study procedures and commitment to the study duration.

Exclusion Criteria:

1. Subject with existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism or excretion of the investigational product.
2. Active or untreated malignancy or has been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for \< 5 years.
3. Subjects with a history of any serious adverse reaction or hypersensitivity to study drug components (includes GLP-1, GIP, glucagon analogs) or have contraindicating diseases.
4. Subjects with confirmed type 1 or type 2 diabetes.
5. Subject is unwilling to avoid consumption of coffee and caffeine-containing beverages within from 24 hours before each study visit and while subjects are confined to the study center.
6. Subject is unwilling to abstain from vigorous exercise from 48 hours prior to admission until the Follow-up visit.
7. History of alcohol abuse as judged by the Investigator within approximately 1 year prior to Screening.
8. History of regular use (defined as ≥ 10 cigarettes per day) of nicotine-containing products (including but not limited to cigarettes, e-cigarettes, pipe, chewing tobacco, nicotine patch or gum) or vaping products within 6 weeks prior to check-in for the first In-house Period.

Primary outcomes:
measure: Part A: Safety and Tolerability
timeFrame: Up to Day 29
measure: Part B: Safety and Tolerability
timeFrame: Up to Day 57
Secondary outcomes:
measure: Part A: Pharmacokinetics
timeFrame: Up to Day 29
measure: Part B: Pharmacokinetics
timeFrame: Up to Day 57
Other outcomes:
measure: Part A: Pharmacodynamics
timeFrame: Up to Day 29
measure: Part B: Pharmacodynamics
timeFrame: Up to Day 57
Locations:
city: Chula Vista
country: United States
facility: ProSciento, Inc.
state: California
Study officials:
References: