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Trial registered on ANZCTR
Registration number
ACTRN12624001397505
Ethics application status
Approved
Date submitted
31/10/2024
Date registered
26/11/2024
Date last updated
27/04/2025
Date data sharing statement initially provided
26/11/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
A Phase 1, single ascending dose study in healthy, overweight and obese participants to investigate safety, tolerability and pharmacokinetics of KAI-9531 subcutaneous injection
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Scientific title
A Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study in healthy, overweight and obese participants to investigate safety, tolerability and pharmacokinetics of KAI-9531 subcutaneous injection
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Secondary ID [1]
313214
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K9531-1701
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metabolic diseases
335514
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Condition category
Condition code
Metabolic and Endocrine
332073
332073
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0
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This is a randomized, double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability and pharmacokinetics (PK) of a single subcutaneous (SC) administration of KAI-9531 at increasing dose levels from 1 to 3 mg. The purpose of the study is to examine the safety, tolerability and PK of KAI-9531 in a non- Asian and Asian population.
Participants will attend the study site between Day -28 to Day -2 (inclusive) for a screening visit. After screening, eligible participants will return to the study site on Day -1 and will be confined until discharge on Day 4 (72 hours). Participants will return to the study site for follow-up visits on Days 5, 6, 8, 14, 22 and Day 29.
KAI-9531 is in clinical development. The method of administration is subcutaneous injection. Upto 50 participants will be enrolled across a total of 5 cohorts. Cohort 1, 2, 3 and 5 will enroll up to 10 (male or female) participants with 8 participants randomized to receive a single SC dose of KAI-9531 and 2 participants randomized to receive placebo. Cohorts 4A and 4B will enroll up to 5 participants each with 4 randomized to receive KAI-9531 and 1 participant randomized to receive placebo. Cohorts 1 to 4A and 4B will consist of participants of non-Asian descent while Cohort 5 will consist of participants of Asian descent. To sequentially escalate to the next cohort dose the PI (or delegate), in consultation with the Medical Monitor (if required) and Sponsor Medical Representative (SMR) will perform safety review in accordance with the Safety Review Committee (SRC) Charter.
KAI-9531 will be administered at the following dose levels via SC injection:
- Cohort 1 - 1 mg
- Cohort 2 - 2 mg
- Cohort 3 - 3 mg
- Cohort 4A- 2 mg
- Cohort 4B (males only)- 3 mg
- Cohort 5 – 2 mg
Placebo will contain excipients in water, without active ingredient.
Study drug will be administered at the study site by trained study site personnel to ensure compliance.
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Intervention code [1]
329788
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Treatment: Drugs
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Comparator / control treatment
Placebo will contain excipients in water, without active ingredient.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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To evaluate the safety and tolerability of a single subcutaneous (SC) dose of KAI-9531 in healthy participants will be assessed as a composite primary outcome.
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Assessment method [1]
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Safety and tolerability will be assessed through vital sign assessment, electrocardiogram assessment (ECG), clinical lab assessments, anti-drug antibodies assessment and collection of serious and non- serious adverse events. Any adverse events during the course of the study will be monitored. TEAEs are AEs that start or worsen after the first dose of study medication. Among healthy subjects who received KAI-9531 the most common adverse reactions related to KAI-9531 with an incidence of greater than or equal to 10% included: nausea, abdominal distension, vomiting, urine ketone body present, and skin pain. Adverse reactions related to KAI-9531 with an incidence of greater than or equal to 5% and less than 10% included: diarrhoea, gastroesophageal reflux disease, dizziness, fatigue and weakness, abdominal pain, hypoglycaemia, and white blood cells urine positive. Adverse events will be assessed by clinical examination and participant self-report. Vital sign assessments will include systolic and diastolic blood pressure, heart rate and respiratory rate and body temperature (only tympanic temperature accepted), measured according to site standard practice.
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Timepoint [1]
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Adverse events: will be assessed throughout the study period on Day -1, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 14, Day 22 and at the End of Study (EoS)/ Early termination (ET) visit. Vital signs: will be assessed throughout the study period at Screening, Day -1, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 14, Day 22 and at the End of Study (EoS)/ Early termination (ET) visit. Electrocardiogram (ECG): will be performed at Screening, Day -1, Day 1 within 1.5 hours pre dose and post-dose, Day 1 (12-hour), Day 2 (24-hour), Day 3 (48-hour), Day 4 (72-hour), Day 5 (96-hour) and Day 6 (120-hour). All ECGs will be in triplicate, conducted within 5 minutes with each recording separated by at least 1 minute. Clinical labs: will be assessed at Screening, Day -1, Day 1, Day 3, Day 5, Day 8, Day 14, Day 22 and at the End of Study (EoS)/ Early termination (ET) visit. Anti-drug antibody (ADA): will be assessed at Day 1, Day 8 and at the End of Study (EoS)/ Early termination (ET) visit.
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Secondary outcome [1]
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Single SC dose urine profiling of KAI-9531 metabolites.
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Assessment method [1]
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The above outcome is assessed by using urine samples. Urine samples are collected to analyse for the presence of urine levels of KAI-9531 metabolites.
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Timepoint [1]
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Urine metabolites time points include Day 1 - 14 hours Day 1 - 24 hours Day 2 -48 hours Day 3 - 72 hours
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Secondary outcome [2]
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Single SC dose plasma profiling of KAI-9531 metabolites.
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Assessment method [2]
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The above outcome is assessed by using blood samples. Blood samples are collected to analyse the assay for the presence of plasma levels of KAI-9531 metabolites.
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Timepoint [2]
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Blood metabolites time points include Day 1 - Predose Day 2 - 24 hours Day 3 - 48 hours Day 4 - 72 hours Day 5 - 96 hours Day 6 - 168 hours
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Secondary outcome [3]
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To measure the pharmacokinetics (PK) of KAI-9531 in plasma following a single SC dose in healthy non-Asian and Asian participants.
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Assessment method [3]
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Blood samples will be collected for the analysis of KAI-9531 concentrations and metabolites and determination of PK parameters in plasma. PK endpoints include (but are not limited to): • Lag Time (Tlag); • Maximum observed concentration (Cmax); • Time to Cmax (Tmax); • Area under the concentration-time curve from 0 to time of last quantifiable concentration (AUC0-last); • Percent AUC extrapolated (AUCextrap%); • Area under the concentration-time curve from 0 to infinity (AUC0-inf); • Apparent terminal half-life (t1/2); • Total apparent body clearance (CL/F)
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Timepoint [3]
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PK time points include - Predose within 0.25hr prior to dosing, postdose - 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 60 hrs, 72 hrs, 96 hrs, 120 hrs, 168hrs, 312 hrs, 504 hrs and 672 hrs.
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Eligibility
Key inclusion criteria
1. Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
2. Are of non-Asian descent and do not identify as being of Asian origin. Asians are defined in this study as participants self-identifying as originating from: Far East, Southeast Asia, or the Indian subcontinent, including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, Vietnam, Mongolia, North Korea, South Korea and Taiwan or having parents or grandparents originating from Asian countries.
3. Body mass index greater than or equal to 22.0 and lesser than or equal to 35.0 kg/m2, with a body weight greater than or equal to 60 kg and lesser than or equal to 130 kg at screening and check-in on Day -1.
4. Medically healthy (in the opinion of the PI or delegate), as determined by pre-study medical history, and without clinically significant abnormalities.
5. Willing and able to comply with modified food and eating habits that reduce nausea and vomiting for this class of drug.
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Known hypersensitivity to the study drug or any of the study drug ingredients.
2. History of anaphylaxis or other significant allergy which, in the opinion of the PI (or delegate), would interfere with the volunteer’s ability to participate in the study (including but not limited to those with a with known allergy to GLP-1 and/or GIP receptor agonists and their excipients).
3. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, within the past 3 months determined by the PI (or delegate) to be clinically relevant.
4. History of surgery or hospitalization prior to screening (1 month prior for minor surgery and 3 months prior for all other surgery), or surgery planned during the study or history of bariatric surgery (at any time).
5. Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
6. Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
7. History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death) or a known arrythmia.
8. Presence or having sequelae of gastrointestinal, liver (including Gilbert’s syndrome), kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
9. A history of or positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomization schedule will be prepared by an unblinded statistician. Participants who meet the study eligibility criteria will be assigned a randomization number pre-dose on Day 1, which corresponds to a study treatment (KAI-9531 or placebo) in accordance with the randomization schedule.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will occur, using a randomization table.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Safety
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Statistical methods / analysis
Detailed methodology for the summarization and statistical analysis of the data collected will be documented in a Statistical Analysis Plan (SAP) that will be finalized before database lock and unblinding of the study.
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
17/12/2024
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Actual
17/12/2024
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Date of last participant enrolment
Anticipated
30/04/2025
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Actual
11/04/2025
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Date of last data collection
Anticipated
30/05/2025
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Actual
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Sample size
Target
50
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Accrual to date
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Final
49
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
27250
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Q-Pharm Pty - Clive Berghofer Research Centre (CBCRC) - Herston
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Recruitment postcode(s) [1]
43332
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4007 - Herston
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Kailera Therapeutics
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Address [1]
317659
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Country [1]
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Kailera Therapeutics
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Address
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Country
United States of America
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Secondary sponsor category [1]
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Commercial sector/Industry
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Name [1]
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Avance Clinical Pty Ltd
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Address [1]
319972
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Country [1]
319972
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Bellberry Human Research Ethics Committee A
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Ethics committee address [1]
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https://bellberry.com.au/
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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16/10/2024
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Approval date [1]
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14/11/2024
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Ethics approval number [1]
316357
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Summary
Brief summary
A Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study in healthy, overweight and obese participants to investigate safety, tolerability and pharmacokinetics of KAI-9531 subcutaneous injection.This is a randomized, double-blind, placebo-controlled single ascending dose study evaluating the safety, tolerability and pharmacokinetics (PK) of a single subcutaneous (SC) administration of KAI-9531 at increasing dose levels from 1 mg to 6 mg.The purpose of the study is to examine the safety, tolerability and PK of KAI-9531 in a non-Asian and Asian population.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Gloria Wong
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Address
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Q-Pharm Pty Ltd, Level 5, 300C Herston Road, Herston, Queensland, 4006
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Country
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Australia
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Phone
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+61 737072720
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Gloria Wong
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Address
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Q-Pharm Pty Ltd, Level 5, 300C Herston Road, Herston, Queensland, 4006
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Country
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Australia
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Phone
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+61737072784
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Gloria Wong
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Address
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Q-Pharm Pty Ltd, Level 5, 300C Herston Road, Herston, Queensland, 4006
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Country
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Australia
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Phone
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+61 737072720
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Fax
137636
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Email
137636
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[email protected]
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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.
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