Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Characteristics of HHT120 in Healthy Subjects

NCT05414734 | Withdrawn Phase 1

• 1 other identifier: DTYX21037PⅠ
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a first in human clinical trial with HHT120. The purpose of this study is to characterize the safety, pharmacokinetic (PK) and Pharmacodynamic (PD) profile of single and multiple twice-daily doses of HHT120 in healthy Subjects and to assess the effects of food on the PK profile of single-dose of HHT120 in healthy Subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• Vital signs

  Abnormal changes in vital signs from baseline

  Up to Day 14

• Physical examination

  Abnormal changes in physical examination from baseline

  Up to Day 14

• Laboratory examination

  Abnormal changes in laboratory examination from baseline

  Up to Day 14

• Electrocardiogram

  Abnormal changes in electrocardiogram from baseline

  Up to Day 14

• Chest radiography

  Abnormal changes in chest radiography from baseline

  Up to Day 14

• Adverse events

  Incidence of adverse events, serious adverse events, adverse events of special interest

  Up to Day 14

• Maximum tolerable dose (MTD)

  Maximum tolerable dose (MTD)

  Up to Day 14

Secondary Outcomes (17)

• Part 1: Cmax

  Up to Day 4

• Part 1: Tmax

  Up to Day 4

• Part 1: t1/2

  Up to Day 4

• Part 1: Vz/F

  Up to Day 4

• Part 1: CLz/F

  Up to Day 4

Study Arms (6)

SAD HHT120

EXPERIMENTAL

Subjects will receive a single dose of HHT120 from 7 doses.

Drug: HHT120

SAD Placebo

PLACEBO COMPARATOR

Subjects will receive a single dose of matched Placebo.

Drug: Placebo

MAD HHT120

EXPERIMENTAL

Subjects will receive a mutiple-dose of HHT120 twice daily for 7 days from 3 doses.

Drug: HHT120

MAD Placebo

PLACEBO COMPARATOR

Subjects will receive a mutiple-dose of matched placebo twice daily for 7 days.

Drug: Placebo

FE K-C

EXPERIMENTAL

Subjects will receive a single dose of HHT120 in the morning in fasted condition in Period 1; followed by a single dose of HHT120 administered in the morning in fed condition in Period 2. A washout period of 7 days will be maintained between 2 periods.

Drug: HHT120

FE C-K

EXPERIMENTAL

Subjects will receive a single dose of HHT120 in the morning in fed condition in Period 1; followed by a single dose of HHT120 administered in the morning in fasted condition in Period 2. A washout period of 7 days will be maintained between 2 periods.

Drug: HHT120

Interventions

HHT120 DRUG

Capsule, oral administration

Also known as: PTI-011-Cl

FE C-K; FE K-C; MAD HHT120; SAD HHT120

Placebo DRUG

Capsule, oral administration

MAD Placebo; SAD Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects who understand and are willing to follow the clinical trial protocol to complete the study and sign the informed consent voluntarily
• ≥50 kg, BMI 19.0-26.0 kg/m2 (including the critical value);
• Those who have been proved healthy by medical history inquiry, physical examination and laboratory examination.

You may not qualify if:

• Have a blood coagulation dysfunction or bleeding tendency, such as repeated bleeding gums, or nearly six months increased risk of bleeding events, or platelet count \< 100 x 109 / L, or always have intracranial hemorrhage (after the accident, for example), gastrointestinal bleeding, purpura, or with active pathological bleeding, bleeding or have any family history, etc.
• History of motor system, nervous/psychiatric system, endocrine system, blood circulation system, respiratory system, digestive system, urinary system, reproductive system abnormalities or existing diseases mentioned above, which the researcher judged to be clinically significant;
• History of drug or food allergy, or are allergic to the active ingredients of the test drug and any excipient ingredients;
• History of postural hypotension, fainting or coma;
• High risk factors of TdP (hypokalemia, hypomagniemia, bradycardia, heart failure, hereditary long QT syndrome, etc.);
• QTc interval greater than 450ms during screening;
• Undergone surgery within 3 months prior to or during screening, or have undergone surgery that affects drug absorption, distribution, metabolism or excretion, or plan to undergo surgery during the study period;
• Blood donation or massive blood loss (≥400 mL) within 3 months before screening or during screening (except female menstrual period);
• History of drug abuse or positive urine drug screening (morphine, THC, methylamphetamine, dimethylene dioxy-amphetamine, ketamine) within 5 years before screening;
• Excessive consumption of tea, coffee or caffeinated beverages (more than 8 cups per day, 1 cup =250 mL) within 3 months prior to screening or during screening;
• Drank regularly within 3 months prior to screening or during screening, i.e. drinking more than 14 units of alcohol per week (1 unit =360 mL beer or 45mL 40% alcohol spirits or 150mL wine), who could not abstain from drinking during the test, or whose alcohol breath test results were \> 0 mg/100mL;
• Smoking ≥5 cigarettes per day in the previous 3 months in the screening period; Or unable to stop using any tobacco products in the treatment period;
• Consumed a large amount of drinks or food (such as grapefruit, grapefruit juice, grapefruit jam, etc.) rich in grapefruit, pomelo, star fruit, mango and dragon fruit within the previous 14 days prior to screening; Or any beverage or food containing grapefruit (i.e. grapefruit), pomelo, star fruit, mango, dragon fruit within 48 hours before the first dose;
• Special dietary requirements, unable to follow the uniform diet or dysphagia;
• Lactose intolerant (who had diarrhea after drinking milk);

Sponsors & Collaborators

• Shanghai Synergy Pharmaceutical Sciences Co., Ltd.: lead

Study Sites (1)

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

Location

Study Officials

• Yiqing Zhao

  Affiliated Hospital of Jiangnan University

  PRINCIPAL INVESTIGATOR

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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 10, 2022
• Study Start: July 1, 2022
• Primary Completion: February 15, 2023
• Study Completion: March 1, 2023
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

CN (1)