A Study to Investigate the Safety, Tolerability and Pharmacokinetics of TESP-0401 in Healthy Part… (NCT07658638) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of TESP-0401 in Healthy Participants
Australia68 participantsStarted 2026-06-16
Plain-language summary
The goal of this intervention study is to evaluate the safety and tolerability of TESP-0401, and to understand how the body processes TESP-0401, in healthy participants after single and multiple doses. The study aims to answer the following questions: 1. What are the safety, tolerability, and pharmacokinetic characteristics of a single dose of TESP-0401 in healthy participants? 2. What are the safety, tolerability, and pharmacokinetic characteristics of multiple doses of TESP-0401 in healthy participants? This study will be a randomized, placebo controlled study.
Who can participate
Age range
18 Years – 65 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
. Participants who are healthy as determined no clinically significant findings by the PI/delegate in medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECG.
. Systolic blood pressure (SBP) ≥110 mmHg at screening measured after at least 10 minutes of rest in the supine position, and on the dosing day prior to administration of study intervention measured after at least 1 hour of rest in the supine position.
. Resting heart rate ≥50 bpm at screening and on the dosing day prior to administration of study intervention, measured after at least 10 minutes of rest in the supine position.
. BMI within the range 18 to 32 kg/m2
. Male participants who refrain from donating sperms and either remain abstinent from sexual intercourse or agree to use protocol-required contraception.
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 with SAEs, TEAEs, with abnormal clinical laboratory tests results, abnormal vital signs, abnormal ECG readings and abnormal physical examination findings
. Female participants who are not pregnant or breastfeeding and are of non-childbearing potential, or if of childbearing potential, agree to use protocol-required contraception and not to donate ova.
. Participants able to provide signed informed consent form.
. Agree to abstain from smoking cigarettes or equivalent nicotine-containing products from 7 days prior to study drug administration through to the end of study visit.
Exclusion criteria
. History or presence of cardiovascular, respiratory including resolved childhood asthma, hepatic, renal, gastrointestinal including cholecystectomy, endocrinological, haematological, immunological, psychiatric including history of depression/anxiety or neurological disorders including migraine capable of (as judged by the PI/delegate) significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
. History of clinically significant hypersensitivity or allergic reactions (e.g. anaphylaxis, angioedema, or severe cutaneous reactions) to any drug or excipient, including components of the study intervention, or a history of multiple drug allergies, which in the opinion of the investigator would place the participant at increased risk or contraindicate participation in the study.
. Abnormal blood pressure determined clinically significant by the PI/delegate.
. Symptomatic herpes zoster within 3 months prior to screening.
. Evidence of active or latent tuberculosis (TB) as documented by medical history, and TB testing consisting of a positive (not indeterminate) TB test such as QuantiFERON-R TB Gold Plus test.
. Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
. Breast cancer within the past 10 years.
. QTc \> 450 msec for male participants or \> 470 msec for female participants.