Safety, Tolerability and Pharmacokinetic Characteristics Evaluation on GST-HG121 Tablets

NCT05576584 | Unknown Phase 1

• 1 other identifier: GST-HG121-I-01
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I clinical study is a phase I clinical study on the safety, tolerability, pharmacokinetic characteristics and food effects of single / continuous administration in Chinese adult healthy subjects

Conditions

Pharmacokinetics; Food Affect; Single Ascending Dose; Maximum Applicable Dose

Keywords

Pharmacokinetics; food affects; Single Ascending Dose; Maximum Applicable Dose

Outcome Measures

Primary Outcomes (1)

• Treatment-Related Adverse Events

  Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0

  SAD up to Day 6 and MAD up to Day 12

Secondary Outcomes (6)

• Peak Plasma Concentration (Cmax)

  Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 120hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24hours on Day1, more details in protocol.

• Area Under Curve (AUC)

  Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 120hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24hours on Day1, more details in protocol.

• T1/2

  Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 120hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24hours on Day1, more details in protocol.

• Cl/F

  Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 120hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24hours on Day1, more details in protocol.

• Ae(0~120h)

  Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 120hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24hours on Day1, more details in protocol.

Study Arms (4)

Single Ascending Dose

PLACEBO COMPARATOR

Five dose groups: 5mg (group I), 15mg (Group II), 30mg (Group III), 60mg (Group IV) and 100mg (Group V). According to the safety, tolerance and PK parameters of group V, higher dose group studies (150mg and 200mg alternatively) are not excluded. There were 10 subjects in each group, of which 8 received GST-HG121 tablets and 2 received placebo.

Drug: GST-HG121 tablets; Drug: Placebo

Multiple Ascending Dose

PLACEBO COMPARATOR

According to the results of single dose study, it is planned to select 1-3 dose groups within the range of single dose for oral administration for 7 consecutive days. There were 12 subjects in each group, of which 10 received GST-HG121 tablets and 2 received placebo. From D 1 to d 7, take GST-HG121 tablets or placebo orally on an empty stomach every day, tentatively once a day (the specific administration frequency may be adjusted based on the results of the single dose increase test)

Drug: GST-HG121 tablets; Drug: Placebo

food affects（A）

PLACEBO COMPARATOR

10 subjects (8 received GST-HG121 tablets and 2 received placebo)

Drug: GST-HG121 tablets; Drug: Placebo

food affects（B）

ACTIVE COMPARATOR

8 subjects (all received GST-HG121 tablets)

Drug: GST-HG121 tablets; Drug: Placebo

Interventions

GST-HG121 tablets DRUG

This trial includes single-dose studies and multiple-dose studies, The single-dose study included 5 dose groups of 5 mg, 15 mg, 30 mg, 60 mg, 100 mg（Alternative groups include 150mg and 200mg）. Based on the results of a single dose, select 1 to 3 doses which are tolerated in SAD to conduct multiple dose studies.

Multiple Ascending Dose; Single Ascending Dose; food affects（A）; food affects（B）

Placebo DRUG

This trial includes single-dose studies and multiple-dose studies, The single-dose study included 5 dose groups of 5 mg, 15 mg, 30 mg, 60 mg, 100 mg（Alternative groups include 150mg and 200mg）. Based on the results of a single dose, select 1 to 3 doses which are tolerated in SAD to conduct multiple dose studies.

Multiple Ascending Dose; Single Ascending Dose; food affects（A）; food affects（B）

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subjects must give informed consent to the test before the test, fully understand the test content, process and possible adverse reactions, and voluntarily sign a written informed consent;
• Able to complete the research according to the requirements of the test scheme;
• Chinese male and female subjects aged between 18 and 55 years old (both inclusive).
• The weight of male subjects shall not be less than 50kg and that of female subjects shall not be less than 45kg. Body mass index (BMI) = body weight (kg) / height 2 (M2), and the body mass index is within the range of 18-28 kg / m2 (including the critical value);
• Effective contraceptive measures can be taken within 6 months from the start of screening to the last administration of the trial drug, and sperm and eggs donation shall be avoided during this period. See Appendix 5 for specific contraceptive measures;
• At the time of screening, there was no history of respiratory, circulatory, digestive, urinary, blood, endocrine, nervous system diseases and metabolic abnormalities with clinical significance;
• At the time of screening, the results of vital signs, physical examination, laboratory examination, electrocardiogram, abdominal color ultrasound (liver, gallbladder, spleen, pancreas, double kidneys) and chest X-ray (positive position) examination were normal or abnormal but judged by the investigator to have no clinical significance.

You may not qualify if:

• Hospitalization within 30 days before the trial administration, or surgical operation within 6 months before the trial administration, or the presence of transplanted organs in the body, or any medical condition that is not suitable for participating in the trial according to the judgment of the investigator;
• Those who have participated in other intervention clinical trials and used clinical study drugs within 3 months before the trial administration or plan to participate in other clinical studies at the same time during the study (if the subjects withdraw from the study before treatment, that is, they are not randomized or treated, they can be included in the study);
• Have been vaccinated with live vaccine within 3 months before the trial administration, or need to be vaccinated during the study period;
• Clinically significant drug allergy history or specific allergic disease history (asthma, urticaria) or known allergy to the test drug or its excipients;
• Blood donation or massive blood loss (\> 450 ml) or use of blood products or blood transfusion within three months before screening;
• Those who smoked more than 5 cigarettes per day on average 3 months before the trial;
• The subjects had a history of alcoholism within 12 months before the screening (drinking 14 units of alcohol every week: 1 unit = 285 ml of beer, 25 ml of liquor, or 100 ml of wine), or the subjects could not use any alcohol containing products within 72 hours before the test administration and during the whole test, or the subjects were positive in the alcohol breath test during the screening period;
• Those with positive urine drug screening (morphine, marijuana) or drug abuse history;
• Taking any prescription medicine, over-the-counter medicine, any health product or herbal medicine within 14 days before screening; Any drug that alters liver enzyme activity was taken 28 days before screening; Inhibitors or inducers combined with the following CYP3A4, P-gp or BCRP, such as itraconazole, ketoconazole or dronedarone;
• Those who have taken special diet (including pitaya, mango, grapefruit, etc.) or had vigorous exercise or other factors affecting drug absorption, distribution, metabolism and excretion within 2 weeks before screening;
• Recent major changes in diet or exercise habits;
• Have a history of dysphagia or any gastrointestinal disease affecting drug absorption;
• Suffering from any disease that increases the risk of bleeding, such as hemorrhoids, gastritis or gastric and duodenal ulcers;
• Subjects who cannot tolerate standard meals (high-fat and high calorie meals) (this article is only applicable to subjects participating in food impact studies);
• Female subjects are breastfeeding or preparing to become pregnant in the near future during the screening period or the test process, or the serum pregnancy results are positive;

Sponsors & Collaborators

• Fujian Akeylink Biotechnology Co., Ltd.: lead
• The First Hospital of Jilin University: collaborator

Study Sites (1)

The first hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

Central Study Contacts

Yanhua Ding, Dr.

CONTACT

+86-18186879768; dingyanhua2003@126.com

Junqi Niu, Dr.

CONTACT

+86-13756661205; junqiniu@aliyun.com

Study Design

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

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: October 12, 2022
• Study Start: July 19, 2022
• Primary Completion: December 28, 2023
• Study Completion: March 30, 2024
• Last Updated: October 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)