A first study in humans to test the safety, tolerability, and how the body processes different single doses of a new imaging agent, KUVA-01, given by intravenous infusion in healthy adult volunteers.
A First-in-Human, Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single, Ascending, Intravenous Doses of the Novel Investigational Imaging Agent, KUVA-01, in Healthy Adult Volunteers
Kuva Labs Pty Ltd.
24 participants
Jan 22, 2026
Interventional
Conditions
Summary
This study will assess whether KUVA-01 a novel MRI imaging agent is safe and well tolerated in healthy adults, compared to a placebo agent (5% glucose). KUVA-01 may be indicated for use in patients with any solid cancer, but a trial of KUVA-01 in healthy volunteers is needed before trials in cancer patients can proceed. Who is it for? You may be eligible for this study if you are aged between 18 and 25 years and are in good general health without a clinically significant medical history. People who have been diagnosed with cancer will not be eligible for this study. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to receive either an infusion of KUVA-01 or a placebo infusion. Both infusions will be administered once only into a vein over a 30 minute period by a registered nurse. Participants in both groups will then be asked to complete an abdominal MRI 2 hours after their infusion. It is hoped this research will demonstrate that KUVA-01 is a safe imaging agent that can be infused without any serious side effects. If this study shows that KUVA-01 is safe and well tolerated, a further study to investigate the imaging effect of KUVA-01 in cancer patients may be undertaken.
Eligibility
Inclusion Criteria19
- Male or female participants aged between 18 and 45 years of age, inclusive at the time of signing the informed consent document.
- Body weight greater than or equal to 50 kg and less than or equal to 100 kg, and body mass index (BMI) within the range of 18 to 32 kg/m2 inclusive at screening.
- Participants must be in good general health, as demonstrated at screening and prior to administration of study treatment by the absence of clinically significant (in the opinion of the Investigator) abnormalities based on a medical evaluation including review of
- medical history, physical examination, safety laboratory tests, vital signs, and 12-lead ECG monitoring.
- Normal vital signs after greater than or equal to 5 min resting in supine position:
- a. Greater than or equal to 90 mmHg and less than or equal to 140 mmHg systolic blood pressure (SBP)
- b. Greater than or equal to 45 mmHg and less than or equal to 95 mmHg diastolic blood pressure (DBP)
- c. Greater than or equal 40 bpm and less than or equal to 100 bpm HR
- d. Body temperature (tympanic) greater than or equal 35°C and less than or equal to 37.7°C
- Triplicate 12-lead ECG, taken after greater than or equal to 5 min in a supine position, with a QT interval corrected using the Fridericia method (QTcF) less than or equal to 450 msec for males and less than or equal to 470 msec for females, PR interval less than or equal to 220 msec or QRS duration less than or equal to 120 msec and no history of long QT syndrome and no clinically significant abnormalities as judged by the Investigator (or qualified designee).
- Understands the requirements of study participation and is willing and able to be confined at the CRU for the specified study period and adhere to the overall study visit schedule, procedures and assessments required by protocol, as assessed by the
- Investigator (or qualified designee).
- Woman of childbearing potential (WOCBP) or fertile male participants must agree to use an acceptable method of contraception from the start of screening until 90 days (male
- participants) or 30 days (female participants) after the final study visit.
- a. Males must be surgically sterile (greater than 30 days since vasectomy with no viable sperm) or, if engaged in sexual relations with a WOCBP, must agree to use an acceptable contraceptive method.
- b. Females or males with same-sex partners (abstinence from penile-vaginal intercourse) or who are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle.
- c. Males must not donate sperm from Day 1 (prior to administration of the study drug) until at least 90 days after administration of the study drug; females must not donate ovum from Day 1 (prior to administration of the study drug) until at least 30 days after administration of the study drug.
- WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to administration of the study treatment and be willing to have additional pregnancy tests, as required, throughout the study.
- Participant understands and voluntarily signs an informed consent document prior to undertaking any study related assessments/procedures.
Exclusion Criteria22
- History of clinically significant central nervous system (CNS), cardiac, pulmonary, metabolic, renal, hepatic, or GI conditions.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), serum creatine, or total bilirubin greater than 1.5x the upper limit of normal (ULN). These laboratory tests may be repeated once if they are abnormal on first screening, and if there is a medical reason to believe the results may be inaccurate. If the repeat test is within the permitted range, the participant may be included in the study only if the Investigator (or qualified designee) considers that the previous finding will not
- compromise the participant’s safety and will not interfere with the interpretation of safety data.
- A positive drug or alcohol screen. A positive drug or alcohol screen test result may be verified by re-testing at the discretion of the Investigator (or qualified designee), with up to 1 false positive result permitted.
- History of regular alcohol consumption within 6 months of screening defined as an average weekly intake of greater than 21 units for men and greater than 14 units for women.
- The participant is unwilling to abstain from alcohol consumption from 24 hours prior to treatment with any study intervention and until discharge from the CRU, and for 24 hours prior to all other outpatient visits to the CRU.
- Use of tobacco or nicotine products exceeding 5 cigarettes (or equivalent) per week in any form within 30 days prior to treatment with the study drugs or unwillingness to refrain from smoking, vaping, or using any nicotine products for the duration of the
- confinement period and for at least 48 hours prior to dosing with the study drugs, and prior to all other outpatient visits to the CRU.
- The participant uses or is planning to use any prescription or non-prescription medications (with the exception of hormonal contraceptives or paracetamol/acetaminophen [up to 2000 mg/per day for a maximum of 3 days]), herbal and dietary supplements, within 5 days or 5 half-lives (whichever is longer) prior to treatment with the study drugs, unless in the opinion of the PI, MM and Sponsor medical representative, the medication is not expected to interfere with the study procedures or compromise participant safety.
- Any significant medical condition, physical or psychiatric illness or history of depression that could, in the Investigator’s (or qualified designee) opinion, compromise the participant’s safety or interfere with the completion of this study.
- Any unstable, pre-existing major medical condition that in the opinion of the Investigator contraindicates the use of the study drugs, including known human immunodeficiency virus (HIV) or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Any condition including the presence of laboratory abnormalities, which according to the Investigator (or qualified designee), places the participant at unacceptable risk if they
- were to participate in the study or may confound the ability to interpret data from the study.
- The participant is pregnant or planning to become pregnant within 90 days of the study or is breastfeeding.
- 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 Investigator (or qualified
- designee).
- Known sensitivity to any component of the study drugs, including 8-PEG20, certepetide, or the placebo (normal physiological saline and glucose).
- Contraindications to or inability to perform the imaging procedures (as applicable) required in this study (e.g., due to weight limits, claustrophobia, inability to undergo MRI due to presence of an implanted or external MRI unsafe device or MR conditional device not meeting the conditions required for the scan).
- Loss or donation of whole blood (greater than 499 mL) within 3 months and/or plasma donation within 2 weeks, prior to dosing with the study drugs or intention to donate blood or blood products during the study.
- Participation in a clinical trial and receipt of an investigational medication within 30 days, 5 half-lives (if known) or twice the duration of the biological effect, whichever is longer, prior to dosing with the study drugs.
- The participant is unwilling or unable to adhere to protocol requirements, and the study visit schedule, or is otherwise unsuitable or unfit for study participation, in the opinion of
- the Investigator, after medical interview, physical examination, and/or screening investigations.
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Interventions
KUVA-01 is an imaging agent comprising of a fixed dose of certepetide co-administered with single ascending doses of 8-PEG20. Each component will be separately reconstituted in normal physiological saline to form stock formulations: Certepetide: 337.5mg in 2mL of normal physiological saline 8-PEG20: 2000mg in 15mL of normal physiological saline The volume of each stock formulation to be combined and administered is dose dependant. Dose escalation will proceed through three planned cohorts: Cohort 1: 3.2mg/kg of participant body weight of certepetide with 6mg/kg of participant body weight of 8-PEG20 Cohort 2: 3.2mg/kg of participant body weight of certepetide with 12mg/kg of participant body weight of 8-PEG20 Cohort 3: 3.2mg/kg of participant body weight of certepetide with 18mg/kg of participant body weight of 8-PEG20 Dose escalation for Cohort 2 and Cohort 3 will be subject to data review and clearance by the study Safety Monitoring Committee (SMC). For each cohort, participants will be randomised in a 3:1 ratio (KUVA-01 : placebo). A sentinel dosing strategy will be used for each cohort: the first two participants (randomised 1:1 KUVA-01: placebo), followed by a 24-hour observation period before dosing the remaining participants in that cohort. The overall randomisation will be 3:1 (KUVA-01 : placebo) per cohort. Both arms are to be administered as a once-off IV infusion on Day 1 over a minimum of 30 minutes (+30 minutes). This will be performed by clinic staff using aseptic non-touch technique by connecting the prepared infusion bag to the participants IV cannula. Then 60 minutes (+120 minutes) after the infusion, KUVA-01 specific abdominal MRI will be undertaken in an imaging subgroup comprised of any 3 post-sentinel participants from each cohort to detect 8-PEG20. Participants will be accompanied by both a physician and a nurse and monitored continuously throughout the infusion and MRI.
Locations(1)
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ACTRN12626000078358