First-In-Human (FIH) Trial Evaluating the Safety and Tolerability of Single and Multiple Ascending Oral Doses of IRL757 in Healthy Volunteers

NCT06493045 | Completed Phase 1 DMC

• 1 other identifier: IRL757C001
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, First-In-Human study evaluating the safety and tolerability of single and multiple ascending oral doses of IRL757 in healthy volunteers.

Conditions

Not Determined

Outcome Measures

Primary Outcomes (6)

• Evaluation of frequency, seriousness and intensity of adverse events

  Until 5-10 days after IMP administration

• Description of physical examination findings

  Until 5-10 days after IMP administration

• Description of electrocardiogram findings

  Until 5-10 days after IMP administration

• Description of vital signs findings

  Until 5-10 days after IMP administration

• Description of safety laboratory measurements

  Until 5-10 days after IMP administration

• Description of C-SSRS (Columbia Suicide Severity Rating Scale) findings

  Until 5-10 days after IMP administration

Secondary Outcomes (5)

• Determination of Maximum Plasma Concentration [Cmax] of IRL757 and its 3 main metabolites

  Until 48 hours post-dose

• Determination of the AUC of IRL757 and its 3 main metabolites after single and multiple dose

  Until 48 hours post-dose

• Determination of the time for maximum concentration [Tmax] of IRL757 and its 3 main metabolites

  Until 48 hours post-dose

• Determination of the half-life [t1/2] of IRL757 and its 3 main metabolites

  Until 48 hours post-dose

• Determination of the renal clearance (CLr) of IRL757 and its 3 main metabolites

  Until 48 hours post-dose

Study Arms (2)

IRL757

EXPERIMENTAL

Drug: IRL757

Placebo Comparator

PLACEBO COMPARATOR

Drug: Placebo

Interventions

IRL757 DRUG

IRL757 capsule

IRL757

Placebo DRUG

Placebo capsule

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willing and able to give written informed consent for participation in the trial.
• Healthy male or female subject aged 18-55 years inclusive.
• Weight of at least 50 kg and no more than 110 kg at screening.
• Willing to use highly effective methods of contraception

You may not qualify if:

• History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the trial, or influence the results or the subject's ability to participate in the trial.
• History or present clinically significant psychiatric diagnosis, at discretion of the Investigator.
• Any suicidal ideation of type 4 or 5 in the C-SSRS in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent).
• History of seizures, including febrile seizure in childhood.
• Any clinically significant illness, medical/surgical procedure or trauma within four (4) weeks of the first administration of IMP.
• Any planned major surgery within the duration of the trial.
• Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV).
• After 10 minutes supine rest at the time of screening, any vital signs values outside the following ranges: Systolic blood pressure \> 140 mm Hg, Diastolic blood pressure \> 90 mm Hg, Heart rate \< 40 or \> 85 beats per minute.
• Prolonged QTcF (\> 450 ms for male subjects or \> 470 ms for female subjects), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the Investigator.
• History of severe allergy/hypersensitivity or on-going allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to IRL757.
• Use of any prescribed or non-prescribed medication including antacids, analgesics, herbal remedies, vitamins and minerals within two (2) weeks prior to the first administration of IMP, except occasional intake of paracetamol (maximum 2 000 mg/day; and not exceeding 3 000 mg/week), at the discretion of the Investigator.
• Administration of another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical trial that included drug treatment within three (3) months of the first administration of IMP in this trial. Subjects consented and screened but not dosed in previous phase I studies are not excluded.
• Current smokers or users of nicotine products. Irregular use of nicotine (e.g. smoking, snuffing, chewing tobacco) less than three (3) times per week is allowed before screening visit.
• History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
• Positive screen for drugs of abuse at screening or on admission to the unit or positive screen for alcohol at screening or on admission to the unit prior to administration of the IMP.

Sponsors & Collaborators

• Integrative Research Laboratories AB: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (1)

CTC Clinical Trial Consultants AB, Uppsala University Hospital

Uppsala, Sweden

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Ascending doses

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: July 9, 2024
• Study Start: May 16, 2024
• Primary Completion: February 7, 2025
• Study Completion: February 7, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)