A Study of HTD1801 in Healthy Subjects (NCT03099603) | Clinical Trial Compass
CompletedPhase 1
A Study of HTD1801 in Healthy Subjects
Australia32 participantsStarted 2017-03-24
Plain-language summary
This is a randomized, double blind, single center, ascending single dose study to evaluate the safety, tolerability, and PK of HTD1801.
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
. Age ≥18 to ≤ 50 years
. Body mass index (BMI) ≥18.0 to ≤ 30.0 kg/m2
. Current non-user of any nicotine containing products (\>6 months)
. Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for ≥12 months. The site will try to retrieve medical records to document the sterility, however, the absence of records will not exclude screening the participant. If medical records cannot be obtained, serum and urine pregnancy testing will be conducted. Postmenopausal status will be confirmed through testing of FSH levels ≥ 40 IU/mL at screening for amenorrheic female participants \<50 years of age.
. Ability to provide written informed consent.
Exclusion criteria
. Participation in an investigational drug study within 30 days prior to dosing or 5 half-lives within the last dose of investigational product whichever is longer.
. Current use of any prescription or over-the-counter (OTC) medications, including herbal products and supplements, within 14 days prior to Day 1 or 5 half-lives, whichever is longer. \[Use of ≤2 g per day of paracetamol (acetaminophen) is allowed prior to and during the study at Investigator discretion. The reason for use must be listed either in the subject's baseline information or as an adverse event.\]
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
Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) after single dose