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Trial registered on ANZCTR


Registration number
ACTRN12625000892415p
Ethics application status
Submitted, not yet approved
Date submitted
17/07/2025
Date registered
18/08/2025
Date last updated
18/08/2025
Date data sharing statement initially provided
18/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A First in Human, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of TT20 Administered Intravenously as Single Dose Infusions and Continuous Infusions in Healthy Adult Volunteers
Scientific title
A First in Human, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of TT20 Administered Intravenously as Single Dose Infusions and Continuous Infusions in Healthy Adult Volunteers
Secondary ID [1] 314842 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal Brain Injury 338110 0
Condition category
Condition code
Neurological 334407 334407 0 0
Other neurological disorders
Reproductive Health and Childbirth 334755 334755 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
TT-20 (liposomal formulation)
Intravenous infusion of TT-20 liposomal injection (10 mg/mL), administered as follows:

Part 1: Single 60-minute Intravenous (IV) infusion on Day 1

Part 2: Continuous Intravenous (IV) infusion over 48 hours

TT-20 is provided in single-use 20 mL vials.TT-20 (liposomal formulation)
Intravenous infusion of TT-20 liposomal injection (10 mg/mL), administered to two separate groups of participants in part 1 and part 2 as follows:

Part 1: Single 60-minute intravenous (IV) infusion on Day 1
Volume of TT-20 to be administered is dose dependant. Part 1 dose cohorts are planned as follows:
Cohort 1: 4.4 mg/kg of participant body weight
Cohort 2: 13.2 mg/kg of participant body weight
Cohort 3: 26.4 mg/kg of participant body weight
Cohort 4: 52.8 mg/kg of participant body weight
Optional Cohort 5: 79.2 mg/kg of participant body weight
Participants will be monitored continuously throughout the infusion

Part 2: Part 2 of the study will be initiated based on the recommendations of the Safety Monitoring Committee (SMC) following review of all safety and available PK data from the completed Part 1 cohorts.
Includes continuous intravenous (IV) infusion over 48 hours
Volume of TT-20 to be administered: To be confirmed based on the outcome of SMC review of part 1 safety and available PK data analysis.
Participants will be monitored continuously throughout the infusion

TT-20 is provided in single-use 20 mL vials.
Intervention code [1] 331448 0
Treatment: Drugs
Comparator / control treatment
Glucose 5% Injection BP (British Pharmacopoeia) is to be used as placebo. It will be administered via intravenous infusion using the same volume and schedule as the investigational product.
Control group
Placebo

Outcomes
Primary outcome [1] 342099 0
Safety and tolerability of TT-20 compared to placebo in healthy adult volunteers
Timepoint [1] 342099 0
Part 1: Day of dose, Day 1, Day 2 and Day 7 post-dose Part 2: Day of dose, Day 1, Day 2, Day 3, Day 4 and Day 9 post-dose
Primary outcome [2] 342156 0
Safety and tolerability of TT-20 compared to placebo in healthy adult volunteers
Timepoint [2] 342156 0
Part 1: Day prior to dosing, Day of dosing, Day 1, Day 2 and Day 7 post-dose. Part 2: Day prior to dosing, Day of dosing, Day 1, Day 2, Day 3, Day 4 and Day 9 post-dose.
Primary outcome [3] 342157 0
Safety and tolerability of TT-20 compared to placebo in healthy adult volunteers
Timepoint [3] 342157 0
Part 1: Day prior to dosing, Day of dosing, Day 1, Day 2 and Day 7 post-dose. Part 2: Day prior to dosing, Day of dosing, Day 1, Day 2, Day 3, Day 4 and Day 9 post-dose.
Secondary outcome [1] 449576 0
To characterize the pharmacokinetics (PK) of ascending doses of TT-20 administered IV as single infusions (Part 1) and as continuous infusions.
Timepoint [1] 449576 0
Day of dose, Day 1 and Day 7 post-dose
Secondary outcome [2] 449762 0
To characterize the pharmacokinetics (PK) of ascending doses of TT-20 administered IV as continuous infusions over 48 hours (Part 2) in healthy adult volunteers.
Timepoint [2] 449762 0
Day of dose, Day 1, Day 2, Day 3 and Day 9 post-dose.
Secondary outcome [3] 450698 0
Safety and tolerability of TT-20 compared to placebo in healthy adult volunteers
Timepoint [3] 450698 0
Part 1: Day prior to dose, day of dose, Day 1, Day 2, and Day 7 post-dose Part 2: Day prior to dose, day of dose, Day 1, Day 2, Day 3, Day 4 and Day 9 post-dose

Eligibility
Key inclusion criteria
1. Men or women who are able and willing to provide written informed consent.
2. Adults equal to or greater than 18 and equal to or less than 55 years, inclusive at the time of informed consent.
3. Body weight equal to or greater than 50 kg and body mass index (BMI) equal to or greater than 18 and equal to or less than 32 kg per m2 at screening and baseline visit (Day -1).
4. Women of childbearing potential (WOCBP) must have used a highly effective method of contraception for at least 28 days prior to dosing on Day 1 and through 30 days after the final study visit. Fertile male participants must agree to use an acceptable method of contraception from the start of screening until 90 days after the final study visit.
5. WOCBP must have abstained from egg donation from at least 28 days prior to dosing on Day 1 and agree to abstain from egg donation through at least 30 days after the final study visit. Fertile male participants must agree to abstain from sperm donation from screening through at least 90 days after the final study visit.
6. Ability and willingness to be confined to the CRU for the required study period and to comply with all protocol procedures and restrictions (e.g., compliance to visit schedule, dietary requirements, alcohol restrictions, etc.).
7. Peripheral venous access is sufficient and suitable for cannulation and repeated venipuncture, and the participant is able to provide blood samples without undue trauma or distress.
8. Participants must be in good general health, as demonstrated at screening and prior to first administration of any study intervention by the absence of clinically significant (in the opinion of the PI or delegate) abnormalities based on a medical evaluation including review of medical history, physical examination findings, safety laboratory tests, vital signs, and 12-lead ECG parameters.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Known hypersensitivity or anaphylactic reaction to food (including egg, soybean, or peanut) or other allergies, or confirmed drug hypersensitivity reaction, including to any of the active ingredients or excipients of the investigational medicinal product (IMP).
2. History of any significant chronic disease (in the opinion of the PI or delegate) including renal (glomerular filtration rate greater than 60 mL per min per 1.73m2 as estimated using the CKD-EPI equation), liver (including but not limited to, Metabolic Dysfunction-Associated Steatotic Liver Disease or Metabolic Dysfunction-Associated Steatohepatitis), endocrine (including but not limited to diabetes mellitus, Type 1 and 2), inflammatory, cardiovascular, gastrointestinal (including but not limited to Crohn’s disease, ulcerative colitis, celiac disease, pancreatic dysfunction, irritable bowel syndrome), neurological (including migraines), psychiatric, neoplastic, or other metabolic disease (including but not limited to familial or acquired lipid metabolism disorders).
Note: Participants with resolved childhood asthma, Gilbert’s disease, or cholecystectomy may be considered for enrollment at the discretion of the PI.
3. History of any acute systemic infection or significant localized infection that has not resolved fully by 1 week prior to admission (Day -1).
4. History of malignancy (with the exception of adequately treated malignancies with an expected 5-year survival rate of greater than 90 percent at the time of diagnosis, e.g., squamous or basal cell carcinoma of the skin, carcinoma in-situ of the breast or cervix).
5. History of loss of consciousness of unknown etiology, convulsions (with the exception of isolated childhood febrile convulsions), or traumatic head injury. Simple concussions occurring more than one year prior to screening are not exclusionary.
6. Has any pre-infusion (i.e., screening, Day -1, or pre-infusion on Day 1) clinically significant ECG abnormalities in the opinion of the PI or delegate. This includes males with QTcF (Fridericia’s correction) greater than 450 msec or females with QTcF greater than 470 msec at any pre-infusion timepoint (i.e., screening, Day -1, or pre-infusion on Day 1).
7. Known diagnosis of prolonged QT interval, history of arrhythmias (with the exception of sinus bradycardia or first-degree atrioventricular block considered to be not clinically significant by the PI or delegate) or previous episode of syncope thought to be of cardiac origin, or a first-degree family history of congenital long QT syndrome or unexplained death.
8. Abnormal vital signs at any pre-infusion timepoint (i.e., screening, Day -1, or pre-infusion on Day 1) as follows:
Systolic blood pressure (SBP) less than 90 or greater than 140 mmHg
Diastolic blood pressure (DBP) greater than 90 mmHg
Pulse rate (PR) less than 40 or greater than 100 bpm
Body temperature (tympanic) equal to or greater than 37.7 degree Celcius.
Vital signs assessment may be repeated once in evaluating this criterion if the PI or delegate believes that the values from the initial assessment were erroneous.
9. If female, positive results on a pregnancy test at screening or Day -1, or breastfeeding or planning to breastfeed during the study.
10. Recent (within the last 3 years) and or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.), and or symptomatic postural hypotension at screening (irrespective of the decrease in BP) or asymptomatic postural hypotension at screening (defined as a decrease in SBP equal to or greater than 20 mmHg 2 minutes after changing from a supine to standing position).
11. Significant psychiatric history (including but not limited to, suicidal attempt within the previous 5 years, psychosis associated with a psychiatric diagnosis, or bipolar disorder). Participants with adequately treated depression or anxiety who have been stable off-treatment for at least 12 months prior to screening may be considered for enrollment at the discretion of the PI.
12. Positive Hepatitis B surface antigen (HBsAg), Hepatitis B virus core antibody (HBcAb), Hepatitis C virus antibodies (HCVAb), or human immunodeficiency virus antibody (HIV Ab) at screening.
13. Use of any prescription medications (with the exception of hormone replacement therapy (post-menopausal females only) or hormonal contraceptives (WOCBP only) within 14 days or 5 half-lives (whichever is longer) of dosing or use of over-the-counter medications (with the exception of paracetamol or acetaminophen, up to 2 g per day) or herbal supplements within 7 days or 5 half-lives (whichever is longer) of dosing, or an anticipated requirement for use of these during the course of the study. Use of antihistamines within 7 days of dosing is excluded. Nutritional supplements may be permitted but must be discussed with the Sponsor’s MM prior to subject enrollment.
14. Use of chronic (more than 14 consecutive days) immunosuppressant or immunomodulatory drugs within the 6 months prior to IMP administration, or isolated (non-chronic) use within 30 days prior to IMP administration.
15. Intake of any nutrients known to modulate cytochrome (CYP) enzyme activity (e.g., grapefruit or Seville orange containing products or quinine containing drinks [tonic water or bitter lemon) within 5 days before dosing and participant is unwilling to abstain from consumption of these products until the final PK sample is collected.
16. History of receiving any vaccine within 14 days prior to randomization.
17. Donation (or loss) of whole blood of 470 mL or more during 56 days prior to IMP administration and or plan to donate whole blood during the study or within 4 weeks after the last study-related blood draw.
18. Donation of plasma or platelets during 14 days prior to IMP administration and or plan to donate plasma or platelets during the study or within 4 weeks after the last study-related blood draw.
19. History of abuse of addictive substances (alcohol, illegal substances) in the 3 years prior to screening, or current use of more than 21 units (men) or 14 units (women) of alcohol per week, drug abuse, or use of illegal substances. Participant must not exhibit abusive behavior of sedatives, hypnotics, tranquilizers, or any other addictive agent including marijuana.
20. Positive alcohol breath test, urine drug screen (for the following analytes: cocaine, phencyclidine, amphetamines, opiates or morphine, benzodiazepines, barbiturates, methadone, THC, methamphetamine, tricyclic antidepressants) at screening or Day -1.
21. Participation in any other clinical interventional study (including screening, dosing, and follow-up) within 30 days or 5 half-lives prior to screening, whichever is longer. If clinical intervention was greater than 6 months prior to screening and the participant is in follow-up only, eligibility may be assessed on a case-by-case basis in consultation with the Sponsor’s MM.
22. Previous participation in a study with an investigational drug or device involving a biological targeted therapy, where final administration of the investigational drug or utilization of the device occurred within 24 weeks prior to first dosing.
23. Smoking more than 5 cigarettes per week (or equivalent, including other nicotine-based products) within 4 weeks prior to IMP administration and or unwillingness to abstain from the use of these during the study (including admission and follow-up).
24. Habitual excessive xanthine consumption (equivalent to greater than 400 mg caffeine per day), and or inability or unwillingness to abstain from caffeine-containing foods and beverages from 7 days prior to dosing until the end of the admission period.
25. Unwillingness to refrain from strenuous physical activity (e.g., heavy lifting, weight or fitness training) from 72 hours prior to admission until the EOS follow-up visit.
26. Clinically significant laboratory abnormalities at screening or Day -1, as judged by the PI or delegate; minor deviations from the normal range may be accepted if judged by the PI or delegate and the Sponsor’s MM to have no clinical relevance, but the following absolute limits apply in addition to clinical judgement:
a. Liver transaminases and or alkaline phosphatase must be equal to or less than 1.2 times Upper Limit of Normal (ULN) (elevated values may be repeated once on a separate day)
b. Triglyceride levels must be equal to or less than 2.1 mmol per L (elevated values may be repeated once on a separate day)
c. Total cholesterol levels must be equal to or less than 1.25 times ULN (elevated values may be repeated once on a separate day)
d. Amylase and or lipase must be equal to or less than ULN (elevated values may be repeated once on a separate day)
e. Platelet counts must be equal to or greater than Lower Limit of Normal (LLN) (values more than 0.9 times LLN may be repeated once on a separate day)
f. International normalized ratio (INR) must be equal to or greater than 0.8 and equal to or less than 1.1, and activated partial thromboplastin time (aPTT) must be within normal limits (INR equal to or less than 1.2 and equal to or greater than 0.8, and an aPTT equal to or less than 1.1 times ULN or equal to or greater than 0.9 times LLN may be repeated once on a separate day).
27. Major surgery within 4 weeks of screening that could interfere with, or for which the treatment might interfere with, the conduct of the study, or that would pose an unacceptable risk to the participant in the opinion of the PI (or qualified delegate).
28. Participant is known to experience significant bruising or bleeding associated with blood draws.
29. Any other condition which in the PI or delegate’s opinion may adversely affect the participant’s ability to complete the study, or which may pose significant risk to the participant.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
17/05/2026
Actual
Date of last data collection
Anticipated
17/05/2026
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 319401 0
Commercial sector/Industry
Name [1] 319401 0
Tellus Therapeutics
Country [1] 319401 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Tellus Therapeutics
Address
Country
United States of America
Secondary sponsor category [1] 321895 0
Commercial sector/Industry
Name [1] 321895 0
Beyond Drug Development
Address [1] 321895 0
Country [1] 321895 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317975 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 317975 0
Ethics committee country [1] 317975 0
Australia
Date submitted for ethics approval [1] 317975 0
16/07/2025
Approval date [1] 317975 0
Ethics approval number [1] 317975 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142746 0
Prof Sepehr Shakib
Address 142746 0
CMAX, Ground Floor, 21-24 North Terrace, Adelaide, SA 5000, Australia
Country 142746 0
Australia
Phone 142746 0
+61 8 7088 7900
Fax 142746 0
Email 142746 0
[email protected]
Contact person for public queries
Name 142747 0
Jaron Ballentine
Address 142747 0
Tellus Therapeutics, 8 Davis Drive, Suite 220 Research Triangle Park, NC 27709
Country 142747 0
United States of America
Phone 142747 0
+1 919 757 5672
Fax 142747 0
Email 142747 0
[email protected]
Contact person for scientific queries
Name 142748 0
Jaron Ballentine
Address 142748 0
Tellus Therapeutics, 8 Davis Drive, Suite 220 Research Triangle Park, NC 27709
Country 142748 0
United States of America
Phone 142748 0
+1 919 757 5672
Fax 142748 0
Email 142748 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.