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

A Phase 1 Randomized, Double-Blind, Two Part Study of the Safety, Tolerability, Pharmacokinetics, Analgesic and Respiratory Effect of KUR-101 in Healthy Adult Participants

This project is testing the safety, tolerability, pharmacokinetics (PK, the amount of study drug in your blood) and pharmacodynamics (PD, how the study drug affects your body) of single doses of a new drug called KUR-101.

Up to 58 healthy men or women aged between 18-55 will be enrolled in this study in two parts.

Part 1 will involve a single ascending (increasing) dose (SAD) where 40 participants (5 groups of 8) will be randomised (assigned randomly, like flipping a coin) to receive a single oral dose of the study drug or placebo. The placebo will look the same as the study drug but will not contain any medicine.

Part 2: will involve a crossover design where 18 participants will be randomised to receive a single oral dose of each of three interventions (study drug, placebo or a marketed form of oxycodone). Each dose is separated by 7 days and the participants are randomised so they do not know the order of the interventions.

For Part 1 the total participation will last 9 days, of which 4 days (3 nights) will be spent in the clinic. One group of subjects in Part 1 will return to the clinic to receive a second dose of drug given with a high fat breakfast. In this group, the total participation will last 16 days, of which 8 days (7 nights) will be spent in the clinic.

For Part 2 the total participation will last 23 days, of which 9 days (8 nights) will be spent in the clinic.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Drug: KUR-101; Drug: Placebo; Drug: OxyNorm

Detailed Description

This is a Phase 1, single-center, prospective, study of orally administered KUR-101 in normal healthy participants. The study will be conducted in two parts.

Part 1 is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, PK, analgesic and respiratory effects of single ascending doses of orally administered KUR-101 in normal healthy participants. Once the MTD has been determined, this dose, or an alternate lower dose, will be taken into Part 2 of the study.

Part 2 is a randomized, double-blind, placebo-controlled, three-period crossover study to assess the analgesic and respiratory effects of a single oral KUR-101 as compared to that of oxycodone in normal healthy participants.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• New Zealand
  • Christchurch, New Zealand, 8011
    • KUR-101-101 Clinical Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Single ascending dose; Single dose of oral KUR-101 or oral placebo	Drug: KUR-101; Single oral dose of KUR-101; Drug: Placebo; Single oral dose of placebo
Experimental: Part 2: Three-way crossover; Single dose of oral KUR-101, oral placebo and oral OxyNorm	Drug: KUR-101; Single oral dose of KUR-101; Drug: Placebo; Single oral dose of placebo; Drug: OxyNorm; Single oral dose of OxyNorm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Safety of KUR-101 when compared with placebo	Measured by the incidence of treatment-emergent adverse events	From the signing of the informed consent through Day 8 in Cohort 1, 2, 4 and 5 and through Day 15 in Cohort 3
Part 2: Effect of KUR-101 on evoked pain response as compared to oxycodone and placebo	Measured using the cold pressor test	Up to 4 hours post dose
Part 2: Effect of KUR-101 on evoked pain response as compared to oxycodone and placebo	Measured using thermal sensory testing	Up to 4 hours post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1 and Part 2: Pharmacokinetics of KUR-101	Measured by levels of KUR-101 in the blood	Up to 48 hours post dose
Part 1: Pharmacokinetics of KUR-101	Measured by levels of KUR-101 in the urine	Up to 48 hours post dose
Part 1: Effect of KUR-101 on respiratory function when compared to placebo	Measured using continuous end-tidal capnography monitoring	Up to 8 hours post dose
Part 1: Effect of KUR-101 on respiratory function when compared to placebo	Measured using pulse oximetry	Up to 8 hours post dose
Part 1: Effect of KUR-101 on respiratory function when compared to placebo	Measured using vital signs monitoring	Up to 8 hours post dose
Part 2: Effect of KUR-101 on respiratory function when compared to placebo and oxycodone	Measured using continuous end-tidal capnography monitoring	Up to 8 hours post dose
Part 2: Effect of KUR-101 on respiratory function when compared to placebo and oxycodone	Measured using pulse oximetry	Up to 8 hours post dose
Part 2: Effect of KUR-101 on respiratory function when compared to placebo and oxycodone	Measured using vital signs monitoring	Up to 8 hours post dose
Part 2: Safety of KUR-101 when compared with placebo and oxycodone	Measured by the incidence of treatment-emergent adverse events	From the signing of the informed consent through Day 22
Part 2: Addictive potential of KUR-101 when compared with placebo and oxycodone	Measured through the Desire for Opioids visual acuity scale	Up to 4 hours post dose
Part 2: Addictive potential of KUR-101 when compared with placebo and oxycodone	Measured through the Addiction Research Center Inventory Morphine Benzedrine Group scale	Up to 4 hours post dose

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Effect of KUR-101 on evoked pain response as compared to placebo	Measured using the cold pressor test	Day 1 up to 4 hours post dose
Part 1: Addictive potential of KUR-101 when compared with placebo	Measured through the Desire for Opioids visual acuity scale	Up to 4 hours post dose
Part 1: Addictive potential of KUR-101 when compared with placebo	Measured through the Addiction Research Center Inventory Morphine Benzedrine Group scale	Up to 4 hours post dose

Collaborators and Investigators

• Sponsor: Kures, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Actual): October 12, 2022
• Study Completion (Actual): October 12, 2022

Study Registration Dates

• First Submitted: October 19, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Estimate): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: KUR-101-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No