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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
26/11/2024
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
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
Secondary ID [1] 313214 0
K9531-1701
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic diseases 335514 0
Condition category
Condition code
Metabolic and Endocrine 332073 332073 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
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 6 mg. The purpose of the study is to examine the safety, tolerability and PK of KAI-9531 in a non- 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 40 participants will be enrolled across a total of 4 cohorts. Each cohort will enrol 8 participants to receive KAI-9531 and 2 participants to receive placebo in a double blinded manner. 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 4- 6 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.

Intervention code [1] 329788 0
Treatment: Drugs
Comparator / control treatment
Placebo will contain excipients in water, without active ingredient.
Control group
Placebo

Outcomes
Primary outcome [1] 339677 0
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.
Timepoint [1] 339677 0
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.
Secondary outcome [1] 440839 0
To measure the pharmacokinetics (PK) of KAI-9531 in plasma following a single SC dose in healthy participants
Timepoint [1] 440839 0
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.
Secondary outcome [2] 440840 0
Single SC dose plasma profiling of KAI-9531 metabolites.
Timepoint [2] 440840 0
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
Secondary outcome [3] 441647 0
Single SC dose urine profiling of KAI-9531 metabolites.
Timepoint [3] 441647 0
Urine metabolites time points include
Day 1 - 14 hours
Day 1 - 24 hours
Day 2 -48 hours
Day 3 - 72 hours

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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

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)
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will occur, using a randomization table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/12/2024
Actual
Date of last participant enrolment
Anticipated
30/04/2025
Actual
Date of last data collection
Anticipated
30/05/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 27250 0
Q-Pharm Pty - Clive Berghofer Research Centre (CBCRC) - Herston
Recruitment postcode(s) [1] 43332 0
4007 - Herston

Funding & Sponsors
Funding source category [1] 317659 0
Commercial sector/Industry
Name [1] 317659 0
Kailera Therapeutics
Country [1] 317659 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Kailera Therapeutics
Address
Country
United States of America
Secondary sponsor category [1] 319972 0
Commercial sector/Industry
Name [1] 319972 0
Avance Clinical Pty Ltd
Address [1] 319972 0
Country [1] 319972 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316357 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 316357 0
Ethics committee country [1] 316357 0
Australia
Date submitted for ethics approval [1] 316357 0
16/10/2024
Approval date [1] 316357 0
14/11/2024
Ethics approval number [1] 316357 0

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

Contacts
Principal investigator
Name 137634 0
Dr Gloria Wong
Address 137634 0
Q-Pharm Pty Ltd, Level 5, 300C Herston Road, Herston, Queensland, 4006
Country 137634 0
Australia
Phone 137634 0
+61 737072720
Fax 137634 0
Email 137634 0
g.wong@nucleusnetwork.com.au
Contact person for public queries
Name 137635 0
Dr Gloria Wong
Address 137635 0
Q-Pharm Pty Ltd, Level 5, 300C Herston Road, Herston, Queensland, 4006
Country 137635 0
Australia
Phone 137635 0
+61737072784
Fax 137635 0
Email 137635 0
brisbane@nucleusnetwork.com
Contact person for scientific queries
Name 137636 0
Dr Gloria Wong
Address 137636 0
Q-Pharm Pty Ltd, Level 5, 300C Herston Road, Herston, Queensland, 4006
Country 137636 0
Australia
Phone 137636 0
+61 737072720
Fax 137636 0
Email 137636 0
g.wong@nucleusnetwork.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.