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Tests treatment safety and results for Healthy Volunteers
Official title A Study to Investigate the Safety, Tolerability and Pharmacokinetics of TESP-0401 in Healthy Participants
ClinicalTrials.gov ID: NCT07658638
What this study is testing
What is TESP-0401?
TESP-0401 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for healthy volunteers.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Participants who are healthy as determined no clinically significant findings by the PI/delegate in medical evaluation including medical history...
- 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...
- 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...
- 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...
You likely can't join if
- History or presence of cardiovascular, respiratory including resolved childhood asthma, hepatic, renal, gastrointestinal including cholecystectomy...
- History of clinically significant hypersensitivity or allergic reactions (e.g. anaphylaxis, angioedema, or severe cutaneous reactions) to any drug or...
- 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...
- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been...
See the full eligibility 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...
- 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.
- 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.
- Willing and able to adhere to study restrictions and to be confined at the CRU.
- History or presence of cardiovascular, respiratory including resolved childhood asthma, hepatic, renal, gastrointestinal including cholecystectomy, endocrinological, haematological, immunological, psychiatric including...
- 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...
- 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.
- eGFR (CKD-EPI method) \<80 mL/min/1.73 m2
- Alanine transaminase (ALT) or aspartate transaminase (AST) \> 1.5 x upper limit of normal (ULN).
- Total bilirubin \> 1.5 x ULN
- Current or chronic history of liver disease. This includes but is not limited to hepatitis virus infections, drug- or alcohol-related liver disease, steatotic liver disease,autoimmune hepatitis, haemochromatosis...
- Presence of hepatitis B surface antigen (HBsAg) at screening.
- Positive hepatitis C antibody test result at screening unless hepatitis C virus ribonucleic acid (HCV-RNA) negative test is documented.
- Individuals with Gilbert syndrome.
- Past or intended use of over-the-counter or prescription medication, including herbal medications, within 30 days or 5 half-lives (whichever is longer) prior to dosing or during the study.
- Live vaccine(s) within 1 month prior to screening, or plans to receive such vaccines during the study.
- Participant who has donated blood (or blood products) or experienced a significant blood loss in excess of 450 mL within 30 days prior to screening, or who plans to donate blood during the study period.
- Receiving or has received any investigational drug (small molecule) or is currently using an investigational device, within 14 days prior to study Day 1, or within 5 elimination half-lives prior to study Day 1...
- Use of any investigational biologic (eg, monoclonal antibody) ≤ 6 months prior to study Day 1.
- Positive drug/alcohol screen at Screening or Day -1.
- Positive cotinine test at admission to the CRU on Day -1.
- Positive human immunodeficiency virus (HIV) antibody test.
- Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of \> 10 units for males or \> 10 units for females.
- History of consuming 5 or more cigarettes or equivalent nicotine-containing products per week within the last 6 months.
- Known history of drug or alcohol abuse within 1 year of Screening.
- Sensitivity to heparin or heparin-induced thrombocytopenia.
- Any other medical condition or social circumstance, which in the opinion of the PI/delegate would impede compliance with or hinder completion of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Charlestown, Suite 301, 99 Pacific Highway,NSW, Australia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlestown, Suite 301, 99 Pacific Highway,NSW, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.