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A Phase 1 Study to Assess the Safety and Effects of Single and Multiple Doses of KS101 in Healthy Volunteers

PHASE1NOT_YET_RECRUITING

This study is the first clinical trial involving study drug KS101. The goal of this clinical trial is to investigate whether KS101 is safe, whether it causes side effects, and how KS101 is broken down in the body, in healthy participants. This information will be used to learn more about KS101 and to determine the most effective dose for age related diseases such as chronic kidney disease and Alzheimer's Disease, with the fewest unwanted side effects.

There are 3 parts to this study. In Part 1, participants will take KS101 or a placebo once and will stay in the study centre for a 4-night inpatient stay. Participants will return for outpatient visits on Days 8 and 29.

In Part 2, participants will take KS101 twice, once after a meal and once without a meal and will stay in the study centre for a 7-night inpatient stay. Participants will return for outpatient visits on Days 11 and 32. In Part 3, participants will take KS101 or a placebo once daily for 5 days and will stay in the study centre for an 8-night inpatient stay.

Participants will return for outpatient visits on Days 12 and 33.

Study details:

This is a Phase 1, 3-part study to evaluate the safety, tolerability, and pharmacokinetic (PK) profile following the oral administration of single and multiple ascending doses of KS101 in healthy participants, including a food effect evaluation. Part 1 will include six single ascending dose cohorts of 8 participants per cohort (randomised 6 active, 2 placebo). For each cohort, a sentinel group of 2 participants (1 active, 1 placebo) will be dosed first.

These participants will be on study for up to 59 days in total. Part 2 will be a crossover evaluation, with and without food (randomised sequence). 12 participants will receive 2 doses of KS101 72 hours apart, one dose under fasting conditions and one dose under fed conditions.

These participants will be on study for up to 61days in total. Part 3 will include three multiple ascending dose cohorts of 8 participants per cohort (randomised 6 active, 2 placebo). These participants will receive one dose for 5 consecutive days and will be on study for up to 63 days in total.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Provided voluntary, written informed consent before any study-specific activities are performed.
  2. Male or female, aged 18 to 55 years inclusive at time of informed consent.
  3. Participants of childbearing potential must agree to the use of a double method of contraception of a highly effective method of birth control combined with a barrier contraceptive when appropriate from screening visit to until 60 days after the last dose of IMP.
  4. Male participants with sexual partners of childbearing potential must agree to use a double method of contraception including condom with a highly effective method of birth control by the partner of childbearing potential from the time of informed consent through to 90 days after the last dose of the IMP.
  5. Non-smoker (or other nicotine use) for at least 32 months before Screening according to history, and urine cotinine <500 ng/mL or carbon monoxide (CO) breath test <10 ppm at Screening and Day -1.
  6. Total body weight ≥50 kg (male) or ≥45 kg (female) and body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive.
  7. Certified as healthy by comprehensive clinical assessment by the Investigator and with suitable veins for cannulation.
  8. Vital signs after 5 minutes resting in supine position.
  9. Standard 12-lead electrocardiogram (ECG) parameters, after 10 minutes in supine position within the specified ranges.
  10. In the opinion of the Investigator, is willing and able to comply with and understand study requirements provided in English and be available for the required study visits.
  11. Is willing to defer blood donations to a blood service for minimum 6 months after the End of study visit.

Exclusion criteria

  1. Liver function tests at Screening and Day -1: aspartate aminotransferase [AST], alanine aminotransferase [ALT],) >2 times upper limit of normal (ULN), serum alkaline phosphatase (ALP) or total bilirubin ≥2 times ULN.
  2. Clinically significant abnormalities in laboratory tests, physical examination, or 12-lead ECG during the Screening period or pre-first dose.
  3. Pregnant or breastfeeding, or planning to become pregnant or breastfeed, or planning to donate ova during study participation; or positive pregnancy test at screening/pre-first dose.
  4. History or presence of clinically relevant cardiovascular, broncho-pulmonary, gastrointestinal, hepatic/gallbladder/bile duct, renal, metabolic, hematological, neurological, musculoskeletal/rheumatological, systemic, ocular, gynaecological, or infectious disease or signs of acute illness.
  5. Any gastrointestinal surgery or condition or disease that could affect drug absorption, distribution, metabolism or excretion.
  6. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer considered treated and cured), treated or untreated, within 5 years before screening.
  7. History of schizophrenia, bipolar disorder psychoses, disorders requiring lithium, attempted or planned suicide, or severe chronic psychiatric diagnosis.
  8. Severe recurring headache (cluster or migrainous headaches) requiring prescription medication.
  9. Donation of >450 mL blood or blood products within 8 weeks before first dose.
  10. Documented evidence of current or past cardiovascular disease including cardiac arrhythmias, significant abnormal cardiac automaticity, or family history of congenital long QT syndrome.
  11. History or presence of diagnosed or treated food or known drug allergy, or any history of anaphylaxis or other severe allergic reactions.
  12. Positive serology test at Screening for hepatitis B surface antigen (HBsAg), hepatitis C (HCV) antibody, or human immune deficiency virus (HIV) antibody.
  13. History of convulsion (including drug or vaccine-induced episodes).
  14. History of alcohol or illicit drug misuse within 2 years before Screening.
  15. Current tobacco smoker or other nicotine use >5 cigarettes or nicotine equivalent per month within 32 months of Screening.
  16. Use of prescription medicines, over-the-counter (OTC) medications, or herbal remedies within 14 days and/or vaccination within 28 days before Day -1.
  17. In the judgement of the Investigator, the individual is likely to be noncompliant or unable to comply with study requirements.
  18. Administered an investigational drug within 90 days before first dose.
  19. Is vegan.
  20. Not willing or able to avoid consumption of grapefruit or Seville oranges or their juices and/or coffee/caffeine-containing beverages within 48 hours before admission.
  21. Identified as a site employee of the Investigator or study centre, with direct involvement in the proposed study.
  22. Considered vulnerable, defined as individuals whose willingness to participate in a clinical study may have been unduly influenced.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE1

trial

Study ID

NCT07143331

Intervention or treatment

DRUG: Part 1 KS101

DRUG: Part 1 Placebo

DRUG: Part 2 with Food

DRUG: Part 2 without food

DRUG: Part 3 KS101

Conditions

  • Healthy Participants
  • Alzheimer Disease
  • Chronic Kidney Disease

  • Condition: Healthy Participants, Alzheimer Disease and more

  • DRUG: Part 1 KS101 and other drugs

  • Sydney, New South Wales, Australia

  • Sponsor: Klotho Sciences Australia Pty Ltd.

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Are you running this trial?

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Research sites nearby

Closest Location:

Scientia Clinical Research

Select from list below to view details:

  • Scientia Clinical Research

    Sydney, New South Wales, Australia

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Who is running the clinical trial?

KSAPL

Klotho Sciences Australia Pty Ltd.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Part 1 KS101
  • Participants will be enrolled in 1 of 6 single ascending dose cohorts. Six participants in each cohort will receive KS101.
Drug: Part 1 KS101
    PLACEBO_COMPARATOR: Part 1 Placebo
    • 6 doses of placebo will be administered to participants
    Drug: Part 1 Placebo
      EXPERIMENTAL: Part 2 KS101 with Food
      • KS101 with food
      Drug: Part 2 with Food
        EXPERIMENTAL: Part 2 KS101 without Food
        • KS101 without food
        Drug: Part 2 without food
          EXPERIMENTAL: Part 3 KS101
          • Multiple ascending doses of KS101
          Drug: Part 3 KS101

            What is the study measuring?

            Primary Outcome

            MeasureDescriptionTime Frame
            To assess the safety and tolerability of single and multiple ascending oral doses of KS101 in healthy adult volunteers.Number of participants reporting treatment emergent adverse events (TEAEs) including treatment-related TEAEs, serious adverse events (SAEs) and TEAEs of severity grade 3 or above.Through to end of study, up to 63 days.
            Evaluation of the safety and tolerability of a single oral dose of KS101 taken after a high-fat meal, assessed by changes observed during the physical examination.Presence of clinically significant changes in participants physical examinations post-first dose.Through to end of study, up to 63 days.
            Evaluation of the safety and tolerability of a single oral dose of KS101 taken after a high-fat meal, assessed by changes in haematology parameters.Presence of clinically significant changes in participants haematology parameters post-first dose.Through to end of study, up to 63 days.
            Evaluation of the safety and tolerability of a single oral dose of KS101 taken after a high-fat meal, assessed by changes in serum biochemistry.Presence of clinically significant changes in participants serum biochemistry parameters post-first dose.Through to end of study, up to 63 days.
            Evaluation of the safety and tolerability of a single oral dose of KS101 taken after a high-fat meal, assessed by changes in coagulation parameters.Presence of clinically significant changes in participants coagulation parameters post-first dose.Through to end of study, up to 63 days.
            Evaluation of the safety and tolerability of a single oral dose of KS101 taken after a high-fat meal, assessed by changes in urinalysis parameters.Presence of clinically significant changes in participants urinalysis parameters post-first dose.Through to end of study, up to 63 days.
            Evaluation of the safety and tolerability of a single oral dose of KS101 taken after a high-fat meal, assessed by changes in vital signs.Presence of clinically significant changes in participants vital signs post-first dose.Through to end of study, up to 63 days.
            Evaluation of the safety and tolerability of a single oral dose of KS101 taken after a high-fat meal, assessed by changes in ECG parameters.Presence of clinically significant changes in participants ECG parameters post-first dose.Through to end of study, up to 63 days.

            Secondary Outcome

            MeasureDescriptionTime Frame
            Pharmacokinetics parameter - High-fat, high-calorie meal effects maximum observed concentration (Cmax).The effect of a standardised high-fat, high-calorie meal on the maximum observed concentration of the study drug in serum will be analyzed for all participants.Through to 7 days post last dose.
            Pharmacokinetics parameter - High-fat, high-calorie meal effects on Area under the curve (AUC).The effect of a standardised high-fat, high-calorie meal on the area under the curve of the study drug in serum will be analyzed for all participants.Through to 7 days post last dose.
            Pharmacokinetics parameter - High-fat, high-calorie meal effects on time for maximum observed Concentration (Tmax).The effect of a standardised high-fat, high-calorie meal on the Serum PK Tmax will be analyzed for all participants.Through to 7 days post last dose.
            Pharmacokinetics parameter - single dose of KS101 effects maximum observed concentration (Cmax).The effect of a single dose of KS101 on the maximum observed concentration of the study drug in serum will be analyzed for all participants.Through to 7 days post last dose.
            Pharmacokinetics parameter - multiple doses of KS101 effects maximum observed concentration (Cmax).The effect of multiple doses of KS101 on the maximum observed concentration of the study drug in serum will be analyzed for all participants.Through to 7 days post last dose.
            Pharmacokinetics parameter - single dose of KS101 effects on Area under the curve (AUC).The effect of a single dose of KS101 on the area under the curve of the study drug in serum will be analyzed for all participants.Through to 7 days post last dose.
            Pharmacokinetics parameter - multiple doses of KS101 effects on Area under the curve (AUC).The effect of multiple doses of KS101 on the area under the curve of the study drug in serum will be analyzed for all participants.Through to 7 days post last dose.
            Pharmacokinetics parameter - single dose of KS101 effects on time for maximum observed Concentration (Tmax).The effect of a single dose of KS101 on the Serum PK Tmax will be analyzed for all participants.Through to 7 days post last dose.
            Pharmacokinetics parameter - multiple doses of KS101 effects on time for maximum observed Concentration (Tmax).The effect of multiple doses of KS101 on the Serum PK Tmax will be analyzed for all participants.Through to 7 days post last dose.
            Pharmacokinetics parameter - single dose of KS101 effects on KS101 half-life (t1/2).The effect of a single dose of KS101 on the KS101 half-life (t1/2) will be analyzed for all participants.Through to 7 days post last dose.
            Pharmacokinetics parameter - multiple doses of KS101 effects on KS101 half-life (t1/2)The effect of multiple doses of KS101 on KS101 half-life (t1/2) will be analyzed for all participants.Through to 7 days post last dose.
            Pharmacokinetics parameter - multiple doses of KS101 effects on its bioavailability (CL/F).The effect of multiple doses of KS101 on its bioavailability (CL/F) will be analyzed for all participants.Through to 7 days post last dose.
            Pharmacokinetics parameter - single dose of KS101 effects on its bioavailability (CL/F).The effect of a single dose of KS101 on its bioavailability (CL/F) will be analyzed for all participants.Through to 7 days post last dose.
            Pharmacokinetics parameter - multiple doses of KS101 effects on the apparent volume of distribution (Vz/F).The effect of multiple doses of KS101 on the apparent volume of distribution (Vz/F) will be analyzed for all participants.Through to 7 days post last dose.
            Pharmacokinetics parameter - single dose of KS101 effects on the apparent volume of distribution (Vz/F).The effect of a single dose of KS101 on the apparent volume of distribution (Vz/F) will be analyzed for all participants.Through to 7 days post last dose.
            Pharmacokinetics parameter - multiple doses of KS101 effects on the apparent elimination rate constant (KEL).The effect of multiple doses of KS101 on the elimination rate constant (KEL) will be analyzed for all participants.Through to 7 days post last dose.
            Pharmacokinetics parameter - single dose of KS101 effects on the elimination rate constant (KEL).The effect of a single dose of KS101 on the elimination rate constant (KEL) will be analyzed for all participants.Through to 7 days post last dose.
            Pharmacokinetics parameter - multiple doses of KS101 effects on the accumulation index (RAC).The effect of multiple doses of KS101 on the accumulation index (RAC) will be analyzed for all participants.Through to 7 days post last dose.
            Investigate the dose proportionality of multiple doses of KS101 on untransformed Cmax.For each Part 3 dose: untransformed Cmax will be analysed for all participants.Through to Day 5.
            Investigate the dose proportionality of multiple doses of KS101 on area under the curve (AUC).For each Part 3 dose: area under the curve (AUC) will be analysed for all participants.Through to Day 5.
            investigate the dose proportionality of single doses of KS101 on untransformed CMAX.For each Part 1 dose: untransformed Cmax will be analysed for all participants.Through to end of study, up to 63 days.
            investigate the dose proportionality of single doses of KS101 on the area under the curve (AUC).For each Part 1 dose: the area under the curve (AUC) will be analysed for all participants.Through to end of study, up to 63 days.
            Are you running this trial?If you're a clinic or sponsor, you can claim this study.
            Claim this trial

            References

            Clinical Trials Gov: A Phase 1 Study to Assess the Safety and Effects of Single and Multiple Doses of KS101 in Healthy Volunteers

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