To Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of IMM-H014 in Healthy Subjects
A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of IMM-H014 Sand the Effects of Food on Pharmacokinetics in Healthy Subjects
1 other identifier
interventional
138
1 country
1
Brief Summary
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single- and multiple-oral doses of IMM-H014 on fasted condition, and characterize PK of IMM-H014 on an empty stomach (fasted condition) and following a high fat, high calorie meal (fed condition) in a 2-period, 2-sequence manner. The study will be conducted in 3 parts (Ascending single dose, multiple dose and food effect). Participants will receive either IMM-H014 or placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 6, 2023
CompletedFirst Submitted
Initial submission to the registry
January 3, 2024
CompletedFirst Posted
Study publicly available on registry
January 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedApril 11, 2025
April 1, 2025
1.5 years
January 3, 2024
April 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adverse Events following oral doses (single, multiple and food effect)of IMM-H014 and placebo
the adverse events are recorded according to the actual occurrence
through study completion, up to 11, 17, 18 days for SAD, MAD, FE part
Number of participants with abnormal laboratory tests results and abnormal physical exam findings
The data of the clinical research center is collected and analyzed according to the time point of the test flow chart
through study completion, up to 4, 10, 11 days for SAD, MAD, FE part
Secondary Outcomes (11)
PK parameters: AUClast（AUC0-t）
Up to 4, 10, 11 days for SAD, MAD, FE part
PK parameters: AUCinf（AUC0-∞）
Up to 4, 10, 11 days for SAD, MAD, FE part
PK parameters: Cmax
Up to 4, 10, 11 days for SAD, MAD, FE part
PK parameters: Tmax
Up to 4, 10, 11 days for SAD, MAD, FE part
PK parameters: t1/2
Up to 4, 10, 11 days for SAD, MAD, FE part
- +6 more secondary outcomes
Study Arms (13)
IMM-H014 /Placebo(single dose) 12.5 mg (Cohort 1)
EXPERIMENTALIMM-H014 /Placebo tablets administered orally once daily under fasted condition.
IMM-H014 /Placebo((single dose) 37.5 mg Cohort(Cohort 2)
EXPERIMENTALIMM-H014 /Placebo tablets administered orally once daily under fasted condition.
IMM-H014 /Placebo(single dose) 75 mg (Cohort 3)
EXPERIMENTALIMM-H014 /Placebo tablets administered orally once daily under fasted condition.
IMM-H014 /Placebo(single dose) 125 mg(Cohort 4)
EXPERIMENTALIMM-H014 /Placebo tablets administered orally once daily under fasted condition.
IMM-H014 /Placebo(single dose and food effect) 175mg (Cohort 5)
EXPERIMENTALPeriod 1 (Day1 to Day4): Group A and Group B receive IMM-H014 /Placebo under the fasting or fed condition ,respectively on Day1. Period 2 (Day 8 to Day11): Group A and Group B receive IMM-H014 /Placebo under the fed or fasting condition ,respectively on Day8.
IMM-H014 /Placebo(single dose) 225 mg (Cohort 6)
EXPERIMENTALIMM-H014 /Placebo tablets administered orally once daily under fasted condition.
IMM-H014 /Placebo(single dose) 275mg (Cohort 7)
EXPERIMENTALIMM-H014 /Placebo tablets administered orally once daily under fasted condition.
IMM-H014 /Placebo(single dose) 325 mg (Cohort 8)
EXPERIMENTALIMM-H014 /Placebo tablets administered orally once daily under fasted condition.
IMM-H014 /Placebo(multiple dose) tentative 37.5 mg(Cohort 9)
EXPERIMENTALIMM-H014 /Placebo tablets administered orally once daily under fasted condition for 7 Days(a total of 7 doses).
IMM-H014 /Placebo(multiple dose) tentative 75 mg(Cohort 10)
EXPERIMENTALIMM-H014 /Placebo tablets administered orally once daily under fasted condition for 7 Days(a total of 7 doses).
IMM-H014 /Placebo(multiple dose) tentative 125 mg(Cohort 11)
EXPERIMENTALIMM-H014 /Placebo tablets administered orally once daily under fasted condition for 7 Days(a total of 7 doses).
IMM-H014 /Placebo(multiple dose) tentative 175 mg(Cohort 12)
EXPERIMENTALIMM-H014 /Placebo tablets administered orally once daily under fasted condition for 7 Days(a total of 7 doses).
IMM-H014 /Placebo(multiple dose) tentative 225 mg(Cohort13)
EXPERIMENTALIMM-H014 /Placebo tablets administered orally once daily under fasted condition for 7 Days(a total of 7 doses).
Interventions
SAD and MAD adopt "sentinel method "which 2 healthy subjects first will receive IMM-H014, and if are evaluated to be tolerable, the remaining 8 subjects will be randomly assigned to receive IMM-H014 and placebo in a ratio of 3:1(10 in per experimental Cohort).
SAD and MAD adopt "sentinel method "which 2 healthy subjects first will receive IMM-H014, and if are evaluated to be tolerable, the remaining 8 subjects will be randomly assigned to receive IMM-H014 and placebo in a ratio of 3:1(10 in per experimental Cohort).
FE part is divided into two groups: 8 subjects will receive IMM-H014 and 2 subjects will receive placebo In group A .All 8 subjects will receive IMM-H014 in group B. Group A adopts "sentinel method ".The treatment in food effect consists of 2 periods.
FE part is divided into two groups: 8 subjects will receive IMM-H014 and 2 subjects will receive placebo In group A .All 8 subjects will receive IMM-H014 in group B. Group A adopts "sentinel method ".The treatment in food effect consists of 2 periods.
Eligibility Criteria
You may qualify if:
- Subjects can voluntarily participate in the clinical trial, sign informed consent before the trial, fully understand the trial content, process and possible adverse events, and complete the study in accordance with the requirements of the trial protocol;
- Subjects can use effective contraceptive methods, such as abstinence, condoms, IUD use, and dual barrier method (such as condom plus diaphragm), within 6 months from the beginning of screening to the last trial drug administration;
- years of age, male and female (including 18 and 45 years);
- Male weight ≥50kg, female weight ≥45kg; Body mass index (BMI) in the range of 18-28 kg/m2 (including the cut-off value); 5）Vital signs and physical examination with normal or abnormal has no clinical significance.
You may not qualify if:
- Clinical history of drug allergy or specific allergic diseases (asthma, urticaria), or known or suspected allergic history to experimental drugs and related excipients;
- Subjects who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines and health products within 2 weeks before screening;
- Clinical laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function, virology examination, thyroid function), abdominal color Doppler ultrasound (liver, gallbladder, spleen, pancreas, kidneys, adrenal gland), chest radiography and other abnormalities with clinical significance; Or other clinically significant diseases (including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases) within 6 months before screening;
- Subjects who ate diets (including grapefruit or grapefruit products, pitaya, mango, etc.) that may affect drug metabolism within 7 days before screening, or had strenuous exercise, or the researchers thought that there were other dieters that affected drug metabolism, absorption, distribution, metabolism and excretion;
- A family history of a first-degree relative (i.e., biological parent, sibling, or child) with a risk factor for tip torsional ventricular tachycardia, or a family history of short QT syndrome, long QT syndrome, sudden unexplained death in youth (less than/etc. 40 years old), or sudden infant death syndrome;
- Subjects who suffer from hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia or hypocalcemia which are abnormal and clinically significant by the investigator;
- Presence of clinically significant abnormalities in ECG or QTcF\>450ms (corrected according to Frederica formula, the calculation method is QTCF = Qt/(RR 0.33));
- Creatinine clearance rate \< 90mL/min (Creatinine clearance calculation Cockcroft-Gault formula: CrCl = \[(140 - age) by weight (kg)\] / \[0.814 x Scr (umol/L)\] or CrCl = (140 - age) by weight (kg) / 72 x Scr (mg/dL), women need to according to the formula calculation results by 0.85);
- Suffering from chronic or active gastrointestinal diseases, such as esophageal diseases, acute gastritis, gastric and duodenal ulcers, enteritis, active gastrointestinal bleeding, or gastrointestinal surgery, which investigators believe is still clinically relevant;
- Subjects who had undergone major surgery (excluding diagnostic surgery) in the six months prior to screening, or who will undergo surgery during the study period, or who had undergone surgery that the investigator determines will affect drug absorption, distribution, metabolism, or excretion;
- Participants who had participated in other clinical trials within 3 months prior to screening (participants can be enrolled if they withdraw from the study before administration of the investigational drug, that is, they have not received the drug);
- Blood donation or significant blood loss (\> 450ml) within 3 months prior to screening;
- Had a history of alcohol abuse (drinking an average of 14 units of alcohol per week in the 3 months prior to screening (1 unit =360 mL beer or 45mL liquor with 40% alcohol or 150 ml wine), or could not abstinence during the test period, or had a positive alcohol breath test;
- Smoking more than 5 cigarettes per day in the 3 months before screening;
- Have a history of drug or drug abuse or urine drug abuse screening positive;
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The first Bethune hospital of Jilin University
Changchun, Jilin, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hong Zhang
The First Hospital of Jilin University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Masking for Participant, Investigator and Clinical Research Associate
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2024
First Posted
January 22, 2024
Study Start
December 6, 2023
Primary Completion
June 1, 2025
Study Completion
August 1, 2025
Last Updated
April 11, 2025
Record last verified: 2025-04