A Study to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics and Food Effect of HGR4113 in Healthy Subjects

Last updated: March 20, 2024
Sponsor: Glaceum
Overall Status: Active - Recruiting

Phase

1

Condition

Diabetes Mellitus, Type 2

Treatment

Placebo

HGR4113

Clinical Study ID

NCT05642377
HGR4113-P1-01
  • Ages 19-50
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

  1. Study Objective: The objective of this study is to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic characteristics, and food effect of HGR4113 after single and multiple oral administration in healthy subjects.

  2. Study Design and Plan: This study is a randomized, double-blind, placebo controlled, single and multiple dosing, dose-escalation phase 1 clinical trial. Volunteers who have been deemed eligible based on the inclusion/exclusion criteria will be given a random number. Each subject will be assigned to one of the dose groups in a 6:2 ratio to HGR4113 (active) or placebo. Subjects will be studied in a double-blind manner and will receive the investigational product per protocol. Dose will be escalated once safety data is collected up to the last pharmacokinetic blood collection timepoint and safety and tolerability has been deemed acceptable following the review of the Safety Review Committee. Assessments including vital signs, 12-lead ECG, clinical laboratory, reproductive hormones, physical examination, and monitoring of adverse events concomitant medications will be conducted to evaluate safety and tolerability. Blood will be collected to evaluate the pharmacokinetic/pharmacodynamic characteristics.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Able to comprehend and willing to sign an informed consent form approved by the IRBbefore Screening.
  2. Adult volunteers between 19 and 50 years of age at Screening.
  3. Body mass index (BMI) between 18.0 and 24.9. ☞ BMI (kg/m^2) = body weight (kg) / (height [m])^2
  4. In good health, determined by no clinically significant findings from medical history,physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratorytests at Screening, or subjects who are deemed acceptable by the Investigatorregardless of the test results.

Exclusion

Exclusion Criteria:

  1. Significant history or clinical manifestation of any hepatic, kidney, neurological,immune, respiratory, endocrine, hematological, neoplastic, or cardiovascular disease,or psychiatric disorder (e.g., mood disorder, obsessive-compulsive disorder).
  2. History of stomach or intestinal disorders (e.g., Chron's disease, ulcer) or surgeries
  • not including appendectomy, hemorrhoidectomy, or herniotomy - which may affect thesafety or pharmacokinetic/pharmacodynamic evaluation of the investigational product.
  1. Significant history or clinical manifestation of hypersensitivity to any drugincluding licorice or other drug (e.g., aspirin, antibiotics).
  2. One or more of the following laboratory test results at Screening:
  • ANC < 1000
  • AST, ALT, GGT, total bilirubin > 1.5x upper limit normal
  • Fasting glucose ≥ 126 mg/dL or HbA1c ≥ 6.5% despite two retests
  • eGFR < 60 (CKD-EPI).
  1. Systolic blood pressure < 90 mmHg or > 150 mmHg, or diastolic blood pressure < 60 mgHgor > 100 mmHg as determined by vital signs monitored after resting in sitting positionfor at least 3 minutes.
  2. History of drug/chemical abuse or tested positive in urine drug screen.
  3. Used or intend to use any prescription medications/products orphytotherapeutic/herbal/plant-derived preparations within 14 days prior to dosing, orany nonprescription medications/products (i.e., over-the-counter (OTC) drugs), healthproducts, or vitamins within 7 days prior to dosing, unless deemed acceptable by theInvestigator.
  4. Participation in any clinical study or bioequivalence study within 6 months prior todosing.
  5. Whole blood donation within 2 months prior to dosing, plasma/platelet donation within 1 month prior to dosing, or receipt of blood products within 1 month prior to dosing.
  6. Alcohol consumption > 21 units/week (1 unit = 10 g of pure alcohol) or unable toabstain from consuming alcohol 3 days prior to first dosing until the lastpharmacokinetic blood sampling.
  7. History of smoking within 90 days prior to dosing (however, participation isacceptable if the subject has quit at least 90 days prior to dosing) or unable toabstain from smoking 90 days prior to dosing until the last pharmacokinetic bloodsampling.
  8. Ingestion of grapefruit-containing foods or beverages 24 hours 3 days prior to dosinguntil the last pharmacokinetic blood sampling, or unable to abstain from ingestingsuch foods or beverages during the same period.
  9. Unable to abstain from ingesting caffeine-containing foods or beverages (e.g., coffee,tea [e.g., black tea, green tea], soft drinks, coffee milk, energy drinks, sportsdrinks) 3 days prior to dosing until the last pharmacokinetic blood sampling.
  10. Females, excluding those who have amenorrhea for at least 12 months or have beensurgically sterilized (e.g., bilateral tubal ligation, bilateral oophorectomy, orhysterectomy), who are pregnant or lactating, evidenced by a positive urine hCGpregnancy test.
  11. Subject or subject's partner is unable or unwilling to use a medically acceptablemeans of contraception during and for 90 days following the last dosing or willing todonate sperm during the same period.
  • Acceptable contraceptive methods include:
  • Use of an intrauterine device that has been proven highly effective
  • Male or female physical contraceptive used with chemical sterilization
  • Surgical sterilization of the subject or the subject's partner (e.g., vasectomy,hysterectomy, tubal ligation, salpingectomy).
  1. Subjects who, in the opinion of the Investigator, should not participate in in thisstudy based on other reasons.
  2. Subject who is confirmed as the CYP2C19 poor metabolizer (e.g., *2/*2, *2/*3, *3/*3)by exploratory genotyping test at Screening in MAD group.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
November 22, 2022
Estimated Completion Date:
January 31, 2025

Connect with a study center

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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