Study to Examine the Safety, Tolerability and Pharmacokinetics of ascending doses of KNX100 in healthy volunteers.
KTX-003: A Phase 1 Study evaluating the Safety, Tolerability and Pharmacokinetics of ascending doses of KNX100 in healthy young and elderly volunteers.
Kinoxis Therapeutics Pty Ltd
12 participants
Mar 24, 2025
Interventional
Conditions
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.
Eligibility
Inclusion Criteria4
- 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.
- Ability to understand and provide written informed consent.
- Body mass index within the range of 18-32 (inclusive).
- Able and willing to comply with the requirements of the study and complete the full sequence of protocol related doses, procedures, and evaluations.
Exclusion Criteria5
- 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.
- Any history or family history (first or second degree relative) of seizure disorder, febrile convulsions or any clinically significant abnormal EEG findings at Screening.
- Any clinically significant medical history of closed head trauma.
- Any history of anaphylaxis or other significant allergy.
- 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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Interventions
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.
Locations(1)
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ACTRN12625000020482