A Study to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of Oral Doses ā¦ (NCT05050188) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of Oral Doses of H008
United States24 participantsStarted 2021-06-24
Plain-language summary
This will be a Phase I, randomized, double-blind, positive- and placebo-controlled study to evaluate the safety, tolerability, and PK/PD of multiple oral doses of H008 in healthy adult subjects.
Two dose levels of H008 at 20 mg and 40 mg will be studied in two sequential cohorts. Each cohort will be enrolled with 12 subjects (8 on H008, 2 on placebo and 2 on positive control drug). Subjects are only allowed to participate in one of the two cohorts. Both the investigational product and placebo will be given in a double blinded manner, while the positive control drug will be given in an open-label manner.Dose escalation to the next cohort will be permitted only when safety data until follow-up and PK data until 48 hours post-last dose, from all subjects in previous cohorts are reviewed, and the investigational product is deemed well tolerated.
The study will consist of a screening period, a baseline period, a 7-day repeated-dose period and a safety follow-up period.
Who can participate
Age range18 Years ā 55 Years
SexALL
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Inclusion criteria
ā. Adult, male and female volunteers, 18 to 55 years of age, inclusive, at the time of dosing.
ā. Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the subject prior to any study-specific procedures).
ā. Willingness and ability to comply with study procedures and follow-up examination.
ā. Body mass index (BMI) ā„18 to ā¤30 kg/m2 and total body weight ā„50.0 kg for males and ā„45.0 kg for females at screening.
ā. Medically healthy on the basis of medical history, and physical examination (including but not limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), as determined by the Investigator at Screening and each Check-In visit.
ā. Medically healthy based on the absence of clinically significant abnormal vital sign measurements, clinical laboratory test results (especially tests for renal and hepatic function) as determined by the Investigator at Screening and Check-In visit.
ā. Medically healthy based on the absence of clinically significant abnormal vital sign measurements, clinical laboratory test results (especially tests for renal and hepatic function) as determined by the Investigator at Screening and each Check-In visit.
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What they're measuring
1
The number and incidence of AEs in HVs of multiple oral dose of H008 (Safety and Tolerability)
Timeframe: Up to final follow-up (Day16) or early termination.
2
The number and incidence of subjects with clinically significant changes of physical examinations (Safety and Tolerability)
Timeframe: Baseline up to Day 16
3
The number and incidence of subjects with abnormal vital signs of multiple oral dose of H008 (Safety and Tolerability)
Timeframe: Baseline up to Day 16
4
The number and incidence of subjects with clinical defined abnormal laboratory tests of multiple oral dose of H008 (Safety and Tolerability)
Timeframe: Baseline up to Day 16
5
The number and incidence of subjects with clinical defined abnormal of 12-lead ECG multiple oral dose of H008 (Safety and Tolerability)
. Non-smokers (including nicotine-containing products) for at least 3 continuous months prior to the first dose.
Exclusion criteria
ā. Subjects who have a history of drug allergy or atopic allergic disease (e.g. asthma, urticaria, eczema, dermatitis, etc.) that were clinically significant, or allergic to any known ingredients and excipients of H008 and other PPIs drugs (e.g., Omeprazole, Lansoprazole, Ilaprazole, Esomeprazole, Rabeprazole, etc.).
ā. History of alcohol or drug/substance abuse (within 2 years).
ā. Positive urine drug screen or alcohol breath test at screening or baseline (Day -2).
ā. Subjects who have history of unexplained syncope or fainting or a condition that predisposes them to syncope, such as hypotension, orthostatic hypotension, bradycardia or dehydration.
ā. Subjects determined by the Investigator to have any medical condition that could jeopardize their health or prejudice study results (e.g., history of surgery of the gastrointestinal tract, which may interfere with absorption, except for appendectomy and cholecystectomy).
ā. Subjects who have used P-gp and/or CYP 450 hepatic microsomal enzyme-inducing or inhibiting drugs (e.g., propafenone, voriconazole, fluconazole, cimetidine) within 30 days of first dosing.
ā. Subjects with history or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease, or active sexually transmitted disease.
ā. History or clinical evidence of achlorhydria, severe gastrointestinal disease, particularly diarrhea or other conditions affecting gastrointestinal mobility or absorption.