Clinical TrialHealthy VolunteersPlaceboPlaceboCompleted

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of KUR-101 in Healthy Adults

Randomised, double-blind Phase I study (n=60) evaluating single oral doses of KUR-101 versus placebo and oxycodone in healthy adults to assess safety, PK/PD, analgesic and respiratory effects.

Target Enrollment
60 participants
Study Type
Phase I interventional
Design
Randomized, quadruple Blind

Detailed Description

This single-centre Phase I study in healthy adults is conducted in two parts: Part 1 is a randomized, double-blind, placebo-controlled single ascending dose (SAD) study to evaluate safety, tolerability, PK and PD of orally administered KUR-101; Part 2 is a randomized, double-blind, three-period crossover comparing KUR-101, placebo and OxyNorm to assess analgesic and respiratory effects.

Part 1 enrols cohorts of 8 (5 cohorts) randomised to active or placebo with one cohort returning for a food-effect assessment; Part 2 enrols participants in a three-way crossover with 7-day washouts between single-dose periods. Outcomes include safety, adverse events, PK parameters, analgesic and respiratory measures.

Study Arms & Interventions

Part 1: SAD

experimental

Single ascending dose, randomised, double-blind, placebo-controlled cohorts (5 cohorts of 8).

Interventions

  • Compound
    via Oral• single dose

    KUR-101 single ascending oral doses (SAD); cohorts of 8 randomised to active or placebo; one cohort receives a second dose with high-fat breakfast for food-effect evaluation.

  • Placebo
    via Oral• single dose

    Matching oral placebo

Part 2: 3-way crossover

experimental

Three-period, randomised, double-blind crossover comparing single oral KUR-101, OxyNorm (oxycodone) and placebo with 7-day washouts.

Interventions

  • Compound
    via Oral• single dose

    KUR-101 single oral dose (dose from Part 1/MRD) given in crossover.

  • Compound
    via Oral• single dose

    OxyNorm (oxycodone) single oral dose as active comparator.

  • Placebo
    via Oral• single dose

    Matching oral placebo

Participants

Ages
18 – 55
Sexes
Male & Female

Inclusion Criteria

  • Healthy male and female subjects;
  • Between 18 and 55 years of age;
  • Provide a signed EC-approved consent form;
  • Generally healthy, in the opinion of the Investigator;
  • Body Mass Index (BMI) 18 to 32 kg/m^2;
  • Using method of contraception;
  • Willing and able to comply with protocol requirements for the duration of the study

Exclusion Criteria

  • Subjects taking prohibited medications;
  • Subjects with a history or presence of clinically significant medical or psychiatric disease;
  • Subjects with a history of recreational or opiate use;
  • Subjects with a history of alcohol abuse or moderate to severe substance abuse;
  • Subjects who have regularly used nicotine-containing products;
  • Subjects with a hospital admission or major illness within 1 month prior to Screening;
  • Subjects with a major surgery within 3 months prior to Screening;
  • Subjects who are pregnant or breastfeeding;
  • Subjects who have participated (taken investigative drug and/or device) in another clinical trial within 30 days prior to Screening;
  • Subjects who belong to a vulnerable population

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment60 participants
  • Timeline
    Start: 2022-02-15
    End: 2022-10-31
  • Compounds
    PlaceboPlacebo
  • Topic
    Healthy Volunteers

Locations

KUR-101-101 Clinical Research Site — Christchurch, New Zealand

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