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Trial registered on ANZCTR
Registration number
ACTRN12625000020482
Ethics application status
Approved
Date submitted
11/12/2024
Date registered
13/01/2025
Date last updated
6/04/2025
Date data sharing statement initially provided
13/01/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Study to Examine the Safety, Tolerability and Pharmacokinetics of ascending doses of KNX100 in healthy volunteers.
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Scientific title
KTX-003: A Phase 1 Study evaluating the Safety, Tolerability and Pharmacokinetics of ascending doses of KNX100 in healthy young and elderly volunteers.
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Secondary ID [1]
313503
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Nil known
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Universal Trial Number (UTN)
U1111-1316-2265
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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:
Mental Health
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Condition category
Condition code
Mental Health
332517
332517
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drug KNX-100, 30mg and 50mg oral capsules
Experimental: Group 1: 5 single ascending doses of KNX100: Day 1: 30mg twice daily (60mg), Day 2: 50mg twice daily (100mg), Day 3: 100mg once daily, Day 30: 80mg twice daily (160mg) and Day 31: 150mg once daily.
Group 2: 2 single ascending doses of KNX100: Day 1: 30mg twice daily (60mg) and Day 20: 80mg twice daily (160mg).
Description: The study will have 2 parts, Part A and Part B. The same set of participants will be involved in both parts. The participants will attend in the clinic and stay inpatient during the dosing. In part A inpatient period for Group 1 is 4 nights. On Days 1-3 the participants will be administered KNX100 oral capsules in ascending fashion starting from 30mg twice daily to 100mg once daily. In part A for Group 2 inpatient period is 2 nights. On Day 1 participants will be administered KNX100 oral capsules 30mg twice daily. There will be break between Part A and Part B to review safety and plasma concentration data of the participants prior to bringing the same set of participants to Part B of the study, The participants will also return to safety monitoring visit prior to start of the Part B. In Part B the inpatient period for Group 1 is 3 nights. On days 30 and 31 the participants will be administered KNX100 oral capsule in ascending fashion starting from 80mg twice daily to 150mg once daily. In Part B for Group 2 the inpatient period is 2 nights. On Day 30 the participants will be administered KNX100 oral capsule 80mg twice daily. The participants will be monitored for safety and return to a follow up visit 7 days after the last dose.
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Intervention code [1]
330074
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Treatment: Drugs
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Safety and tolerability of ascending doses of KNX100 administered as a single dose once daily or twice daily.
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Assessment method [1]
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Adverse Events seriousness, incidence, frequency and severity measured by results of investigator observations, vital signs, ECG, EEG, physical and neurological examination. Side effects possibly related to KNX100 (more than or equal to 1%, but less than 10% of participants in a previous clinical study) are drowsiness or sleepiness and dizziness.
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Timepoint [1]
340037
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TEAE/SAE reports from first dose up to follow up, change in laboratory testing and in clinical observations from baseline. The participants will be monitored for above safety and tolerability assessments throughout their in-patient stay (Group 1: Part A: Days 1 to 4 and Part B: Days 30-32 and Group 2: Part A: Days 1 to 2 and Part B: Days 30 to 31) in the clinical unit, and will have a follow up outpatient visit a week after Part A and a week after Part B have completed.
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Secondary outcome [1]
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The secondary objective is to determine the Pharmacokinetic (PK) profile of KNX100 following administration of ascending doses of KNX100 administered orally as a single dose once daily or twice daily.
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Assessment method [1]
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Plasma samples will be assessed for total exposure, maximum plasma concentration, time to maximum plasma concentration, terminal elimination half-life and other relevant PK parameters.
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Timepoint [1]
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PK samples will be collected pre-dose and up to 12h post-dose on dosing days. During the dosing days (Group 1: Days 1-3 and Days 30-31 and Group 2: Day 1 and Day 30) when the dose is administered twice daily, the PK samples are collected at following timepoints: pre-dose, 0.5h, 1h, 2h, 4h and 8h post dose. When the dose is administered once daily, the PK samples are collected at following timepoints: pre-dose, 0.25h, 0.5h, 1h, 2h, 4h and 8h and 12h post dose.
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Eligibility
Key inclusion criteria
1. Healthy male and female volunteers greater than or equal to 18 and less than or equal to 64 years old (Group 1) and greater than or equal to 65 years old (Group 2) at Screening.
2. Ability to understand and provide written informed consent.
3. Body mass index within the range of 18-32 (inclusive).
4. Able and willing to comply with the requirements of the study and complete the full sequence of protocol related doses, procedures, and evaluations.
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Minimum age
18
Years
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Maximum age
No limit
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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. Clinically significant history or presence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, haematological, neurological, or psychiatric disorder making implementation of the protocol or interpretation of the study results difficult, or that would put participants at risk in the opinion of the Investigator. Any surgical or medical history which may significantly alter the absorption, metabolism, or elimination of drugs or constitute a risk when taking the study intervention; or interfering with the interpretation of data (e.g., gastric bypass, cyclical vomiting, etc.). This includes a history of lymphoma, leukemia, or any malignancy within 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.
2. Any history or family history (first or second degree relative) of seizure disorder, febrile convulsions or any clinically significant abnormal EEG findings at Screening.
3. Any clinically significant medical history of closed head trauma.
4. Any history of anaphylaxis or other significant allergy.
5. Any current diagnosis or clinically significant medical history of psychiatric illness as diagnosed and documented by a medical practitioner and as defined by the American Psychiatric Association DSM-5 making implementation of the protocol or interpretation of the study results difficult, or that would put the participant at risk in the opinion of the Investigator.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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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
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
24/03/2025
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Actual
24/03/2025
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Date of last participant enrolment
Anticipated
30/04/2025
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Actual
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Date of last data collection
Anticipated
4/06/2025
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Actual
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Sample size
Target
12
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Accrual to date
8
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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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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Kinoxis Therapeutics Pty Ltd
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Kinoxis Therapeutics Pty Ltd
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
320287
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Address [1]
320287
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Country [1]
320287
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
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https://www.alfredhealth.org.au/research/ethics-research-governance
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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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09/12/2024
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Approval date [1]
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31/01/2025
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Ethics approval number [1]
316626
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Summary
Brief summary
This is Phase 1, single treatment, two-period (Part A and B), two-group (Group 1 and 2), open-label study of ascending doses of KNX100 administered to healthy volunteers once or twice daily. Up to 5 dose cohorts, ranging from 30mg twice daily (60mg) to 80 mg twice daily (160 mg) of KNX100 will be evaluated. Approximately 6 male and female adult healthy volunteers will be enrolled in Group 1, and approximately 6 elderly, male and female healthy volunteers, 65 years of age and over, will be enrolled in Group 2. The same set of participants will be involved in both parts A and B. The participants will attend in the clinic and stay inpatient during the dosing. In part A inpatient period for Group 1 is 4 nights and for Group 2 it is 2 nights. There will be approximately 3 weeks rest period between Part A and Part B. In Part B inpatient period for Group 1 is 3 nights and for Group 2 it is 2 nights.
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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 Philip Ryan
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Address
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Nucleus Network Melbourne, Level 5, Burnet Tower, 89 Commercial Rd, Melbourne, Victoria, 3004
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Country
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Australia
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Phone
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+61 03 8593 9801
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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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Tiina Ahveninen
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Address
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Kinoxis Therapeutics, Suite 201, 697 Burke Road, Camberwell, VIC 3124
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Country
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Australia
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Phone
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+61 1800 460 409
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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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Tiina Ahveninen
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Address
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Kinoxis Therapeutics, Suite 201, 697 Burke Road, Camberwell, VIC 3124
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Country
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Australia
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Phone
138452
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+61 1800 460 409
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Fax
138452
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Email
138452
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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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