RecruitingPhase 1ACTRN12624000245594

A Phase I, Randomized, Double-blind, Placebo-controlled, Single-Ascending-Dose (SAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of XG2002 Oral Administration in Healthy Adult Volunteers

Sponsor

Xgene Pharmaceutical Pty Ltd

Enrollment

32 participants

Start Date

Apr 15, 2024

Study Type

Interventional

Conditions

Acute and Chronic Pain

Summary

This is a randomised, double-blind, placebo-controlled, First-in-Human Study to assess the safety ofXG2002 and how this drug acts in the body in healthy volunteers. XG2002 may be indicated for use in patients with acute and chronic pain, but a trial of the drug in healthy volunteers is needed before trials in patients suffering from acute and chronic pain can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 65 years and are in good general health without a clinically significant medical history. Study details All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive either a single dose of XG2002 or placebo. All participants will have their vital signs checked (heart rate, blood pressure with Core Body Temperature (CBT) being measured by an ingested real-time monitoring device), and will provide blood and urine samples for testing. If the drug appears safe, additional participants will be assigned by chance to receive a larger single dose of XG2002 or placebo, followed by blood and urine testing. This will continue until a maximum safe dose is determined. It is hoped this research will determine the maximum dose of XG2002 that can be administered safely without causing severe reactions. Once the dose of XG2002 has been determined in healthy volunteers, a trial investigating the efficacy of XG2002 as a treatment for patients with acute and chronic pain may proceed.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

Chronic and acute pain affects millions of people, yet many available pain medications come with significant side effects or the risk of dependence. XG2002 is a new experimental drug designed to treat pain through a different mechanism than existing medications. Before it can be tested in people with pain conditions, its safety needs to be established in healthy volunteers. This first-in-human study will test escalating single doses of XG2002 against a placebo in healthy adults to determine the maximum safe dose. Participants will have their vital signs monitored, provide blood and urine samples, and swallow a small temperature-monitoring capsule that tracks core body temperature in real time. The study will continue testing higher doses only if each previous dose level is confirmed safe. You may be eligible if you are 18 to 65 years old, in good general health with no significant medical history, and weigh at least 60 kg. Non-smokers or very light smokers only. People with major medical conditions, liver or kidney abnormalities, HIV or hepatitis, positive drug screens, or who have taken prescription medication recently are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This is a double-blind, placebo-controlled, randomised, single dose escalation study. Approximately 48 participants will be enrolled sequentially into six ascending dose cohorts and will be randomised to receive either XG2002 or placebo as an oral capsule on Day 1. Participants in each cohort will be required to fast for approximately 10 hours overnight prior to dosing on Day 1 with the dose ranging from 10 mg - 800mg of either XG2002 or matching placebo. Core Body Temperature (CBT) will be measured by an ingested real-time monitoring device. Dose escalation in each successive dose cohort will proceed in a sequential fashion after all relevant safety and tolerability data from all completed cohorts including the preceding dose cohort(s) have been reviewed by the Safety Review Committee (SRC). If it is not appropriate to escalate the dose level according to the proposed dose escalation schedule or intolerable dose level encountered (i.e., Stopping Criteria met), then an alternative sub-level dose may be given following discussion between the Sponsor and SRC (for example, if 800 mg dose is the intolerable dose, a cohort for 600 mg may be tested). Adherence to study intervention will be conducted by study staff and recorded in the source document.

Locations(1)

CMAX Clinical Research Pty Ltd - Adelaide

SA, Australia

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ACTRN12624000245594