Phase 1 Study for IPG11406 in Health Volunteer (NCT06255834) | Clinical Trial Compass
CompletedPhase 1
Phase 1 Study for IPG11406 in Health Volunteer
China66 participantsStarted 2024-02-24
Plain-language summary
A phase 1, randomized, double-blind, placebo-controlled, single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and food effect of orally administered IPG11406 in healthy adult participants
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy volunteers aged between 18 and 50 years old, both male and female, are required. Participants must undergo medical history investigation, physical examination, vital signs examination, electrocardiogram, chest X-ray examina-tion, and laboratory tests during the screening period to ensure good health.
. The body mass index (BMI) is between 18 and 32, calculated as: BMI= weight(kg)/ height 2(m 2);
. Participants were required to be in a non-menstrual, non-pregnant, and non-lactating period during the trial and to agree to have no childcare plans for the next 6 months.
. Physical health, defined as: detailed and clear medical history, comprehensive physical examination (including blood pressure and pulse rate, laboratory tests, and 12-lead electrocardiogram) with no clinical abnormalities detected;
. After 10 minutes of supine position testing, vital signs should be within the following range: 95 mmHg \<systolic blood pressure (SBP) \<140 mmHg 45 mmHg \<Diastolic Blood Pressure (DBP) \<90 mmHg 45 bpm \<Heart Rate (HR) \<90 bpm
. After 10 minutes of resting supine position, 12-lead ECG readings: PR interval\<120 ms \<220 ms, QRS complex \<120 ms, QTc (Fridericia recommendedalgorithm) ≤450 ms, normal ECG; or abnormal ECG results deemed clinically insignificant by the investigator.
. Laboratory test results must fall within the normal range (or within the established screening threshold) or show no clinically significant abnormalities; however, serum creatinine, alkaline phosphatase, and liver enzymes (aspartate aminotransferase,Alanine aminotransferase (ALT) should not exceed the upper limit of the laboratory normal range. Total bilirubin should not exceed 1.5 times the upper limit of the normal range for conjugated bilirubin (unless the subject has a history of Gilbert syndrome).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety Indicators:Adverse Event
Timeframe: from first dose until end of follow-up, up to 17 days
. Willing and able to comply with all treatment, and laboratory testing protocols, agree to take the oral test medication, and meet other study requirements