Not DeterminedPhase 1NCT06493045

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

A Phase 1 study testing IRL757 in people with Not Determined, run by Integrative Research Laboratories AB at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Not Determined
What is being tested?: IRL757
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 82 participants
Where: 1 siteSweden
Study dates: 16 May 2024to 7 Feb 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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.

Show all 19Show fewer

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.
Use of anabolic steroids.
Current excessive use of caffeine, as judged by the Investigator.
Plasma donation within one (1) month of screening or any blood donation/blood loss > 450 mL during the three (3) months prior to screening.
Investigator considers the subject unlikely to comply with trial procedures, restrictions and requirements.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

CTC Clinical Trial Consultants AB, Uppsala University Hospital
Uppsala

Other trials in Sweden

About this study

Official title: A Prospective, Single-centre, Randomised, Double-blind, Placebo-controlled, Phase I, First-In-Human (FIH) Trial Evaluating the Safety and Tolerability of Single and Multiple Ascending Oral Doses of IRL757 in Healthy Volunteers

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.

Read the detailed description

The trial is composed of two parts: Single Ascending Dose (SAD) part and Multiple Ascending Dose (MAD) part.

The SAD part of the trial will be a parallel group design with one pre-defined starting dose and up to four tentative ascending dose levels of IRL757. Eligible and consenting participants will be included in one of five cohorts, with 8 participants in each cohort (ratio 1:3 placebo/IRL757).

The MAD part of the trial will start after completion of the SAD part of the trial. Depending on the data from the SAD part, two or three dose levels will be evaluated in the MAD part of the trial. There will be 12 participants in each cohort (ratio 1:3 placebo/IRL757).

At the screening visit, consenting subjects will be screened for eligibility according to study specific inclusion/exclusion criteria within 4 weeks before Investigational Medicinal Product (IMP) administration.

If eligible, participants will be admitted to the phase 1 clinic for allocation and administration of the IMP: single dose in the SAD part of the trial or repeated dose (treatment administered repeatedly for 10 days) in the MAD part of the trial. Participants will receive IRL757 or placebo, as randomized.

The treatment allocation will be double-blind, i.e. it will not be disclosed to the patients, the site staff or the Sponsor.

A follow-up visit will be performed for all participants, 5-10 days after IMP administration.

Safety assessments will be performed throughout the study: review and collection of adverse events, physical examination, suicidality ideation, electrocardiogram recording, vital signs, safety laboratory assessments. Blood and urine sampling will also be performed for determination of pharmacokinetic parameters.

Conditions: Not Determined
Being tested: IRL757, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IRL757Drug
IRL757 capsule
PlaceboDrug
Placebo capsule

Study groups in NCT06493045
Study group	Role	What they receive
IRL757	Experimental	Not described Receives: Drug: IRL757
Placebo Comparator	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluation of Frequency, Seriousness and Intensity of Adverse Events
Total number of AEs, and total number of AEs by severity and relationship to study treatment are presented. Refer to the Adverse Events section for more information
Measured: Until 5-10 days after IMP administration
Description of Physical Examination Findings
Number of participants with clinically significant abnormal findings on physical examination
Measured: Until 5-10 days after IMP administration
Description of Electrocardiogram Findings
Number of participants with clinically significant abnormal electrocardiogram findings
Measured: Until 5-10 days after IMP administration
Description of Vital Signs Findings
Number of participants with clinically significant abnormal vital signs findings
Measured: Until 5-10 days after IMP administration
Description of Safety Laboratory Measurements
Number of participants with clinically significant abnormal safety laboratory measurements
Measured: Until 5-10 days after IMP administration
Description of C-SSRS (Columbia Suicide Severity Rating Scale) Findings
Number of Participants With Suicidal Thoughts or Attempts
Measured: Until 5-10 days after IMP administration

Secondary outcomes (5)

Determination of Maximum Plasma Concentration [Cmax] of IRL757 and Its 3 Main Metabolites
Geometric mean and geometric coefficient of variation (CV%) for maximum plasma concentration. Data from Pharmacokinetic analysis set. All samples from all participants were subject to analysis of IRL757 and main metabolite concentrations.
Measured: Until 48 hours post-dose
Determination of the AUC of IRL757 and Its 3 Main Metabolites After Single and Multiple Dose
Geometric mean and geometric coefficient of variation (CV%) for area under the plasma concentration-time curve (AUC0-inf for SAD and AUC0-tau for MAD). Data from Pharmacokinetic analysis set. All samples from all participants were subject to analysis of IRL757 and main metabolite concentrations.
Measured: Until 48 hours post-dose
Determination of the Time for Maximum Concentration [Tmax] of IRL757 and Its 3 Main Metabolites
Median time to maximum plasma concentration with full range (minimum, maximum). Data from Pharmacokinetic analysis set. All samples from all participants were subject to analysis of IRL757 and main metabolite concentrations.
Measured: Until 48 hours post-dose
Determination of the Half-life [t1/2] of IRL757 and Its 3 Main Metabolites
Geometric mean and geometric coefficient of variation (CV%) for terminal elimination half-life. Data from Pharmacokinetic analysis set. All samples from all participants were subject to analysis of IRL757 and main metabolite concentrations.
Measured: Until 48 hours post-dose
Determination of the Renal Clearance (CLr) of IRL757
Geometric mean and geometric coefficient of variation (CV%) for renal clearance. Data from Pharmacokinetic analysis set. All samples from all participants were subject to analysis of IRL757 and main metabolite concentrations.
Measured: Until 48 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 May 20247 Feb 2025

First posted9 Jul 2024
Study start16 May 2024
Primary completion7 Feb 2025
Study completion7 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Not DeterminedStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Ascending doses
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06493045
Sponsor's protocol ID: IRL757C001
Status last verified: Apr 2026
First submitted: 29 May 2024
Last updated: 15 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Single-centre, Randomised, Double-blind, Placebo-controlled, Phase I, First-In-Human (FIH) Trial Evaluating the Safety and Tolerability of Single and Multiple Ascending Oral Doses of IRL757 in Healthy Volunteers
ClinicalTrials.gov ID: NCT06493045
Acronym / sponsor ID: IRL757C001
Conditions: Not Determined
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: Integrative Research Laboratories ABIndustry (pharma, biotech, devices)
Collaborators: Michael J. Fox Foundation for Parkinson's Research
Study start: 16 May 2024 (actual)
Primary completion: 7 Feb 2025 (actual)
Study completion: 7 Feb 2025 (actual)
First posted: 9 Jul 2024 (actual)
Results: Posted 15 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

The trial is composed of two parts: Single Ascending Dose (SAD) part and Multiple Ascending Dose (MAD) part.

The treatment allocation will be double-blind, i.e. it will not be disclosed to the patients, the site staff or the Sponsor.

A follow-up visit will be performed for all participants, 5-10 days after IMP administration.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Ascending doses

Arm	Type	Receives
IRL757	Experimental	Drug: IRL757
Placebo Comparator	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (19 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IRL757IRL757 capsule	Drug	IRL757
PlaceboPlacebo capsule	Drug	Placebo Comparator

Primary outcome

Evaluation of Frequency, Seriousness and Intensity of Adverse Events
Time frame: Until 5-10 days after IMP administration
Total number of AEs, and total number of AEs by severity and relationship to study treatment are presented. Refer to the Adverse Events section for more information
Description of Physical Examination Findings
Time frame: Until 5-10 days after IMP administration
Number of participants with clinically significant abnormal findings on physical examination
Description of Electrocardiogram Findings
Time frame: Until 5-10 days after IMP administration
Number of participants with clinically significant abnormal electrocardiogram findings
Description of Vital Signs Findings
Time frame: Until 5-10 days after IMP administration
Number of participants with clinically significant abnormal vital signs findings
Description of Safety Laboratory Measurements
Time frame: Until 5-10 days after IMP administration
Number of participants with clinically significant abnormal safety laboratory measurements
Description of C-SSRS (Columbia Suicide Severity Rating Scale) Findings
Time frame: Until 5-10 days after IMP administration
Number of Participants With Suicidal Thoughts or Attempts

5 secondary outcomes

Determination of Maximum Plasma Concentration [Cmax] of IRL757 and Its 3 Main Metabolites
Time frame: Until 48 hours post-dose
Determination of the AUC of IRL757 and Its 3 Main Metabolites After Single and Multiple Dose
Time frame: Until 48 hours post-dose
Determination of the Time for Maximum Concentration [Tmax] of IRL757 and Its 3 Main Metabolites
Time frame: Until 48 hours post-dose
Determination of the Half-life [t1/2] of IRL757 and Its 3 Main Metabolites
Time frame: Until 48 hours post-dose
Determination of the Renal Clearance (CLr) of IRL757
Time frame: Until 48 hours post-dose

Results and safety

Results posted to the registry on 15 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SAD Cohort 1	6	6
SAD Cohort 2	6	6
SAD Cohort 3	6	6
SAD Cohort 4	6	6
SAD Cohort 5	6	6
SAD Placebo Cohort	10	10
SAD Food Interaction Sub-study	6	6
MAD Cohort 1	9	9
MAD Cohort 2	9	9
MAD Cohort 3	9	9
MAD Placebo Cohort	9	9

Primary outcome: Evaluation of Frequency, Seriousness and Intensity of Adverse Events

Time frame: Until 5-10 days after IMP administration. Number. Unit: Adverse events

Measure	SAD Cohort 1 n = 6	SAD Cohort 2 n = 6	SAD Cohort 3 n = 6	SAD Cohort 4 n = 6	SAD Placebo Cohort n = 10	SAD Food Interaction Sub-study n = 6	MAD Cohort 1 n = 9	MAD Cohort 2 n = 9	MAD Cohort 3 n = 9	MAD Placebo Cohort n = 9
Any AE	7	1	3	4	9	9	16	18	9	19
Relationship to study treatment - Not Related	3	1	2	3	2	3	7	11	4	5
Relationship to study treatment - Possible	4	0	1	1	6	6	9	7	5	14
Relationship to study treatment - Probable	0	0	0	0	1	0	0	0	0	0
Severity - Mild	7	1	3	4	9	9	15	18	9	19
Severity - Moderate	0	0	0	0	0	0	1	0	0	0

Population analysed: Total number of AEs are presented

Primary outcome: Description of Physical Examination Findings

Time frame: Until 5-10 days after IMP administration. Count of participants. Unit: Participants

Measure	SAD Cohort 1 n = 6	SAD Cohort 2 n = 6	SAD Cohort 3 n = 6	SAD Cohort 4 n = 6	SAD Cohort 5 n = 6	SAD Placebo Cohort n = 10	SAD Food Interaction Sub-study n = 6	MAD Cohort 1 n = 9	MAD Cohort 2 n = 9	MAD Cohort 3 n = 9	MAD Placebo Cohort n = 9
Value	0	0	0	0	0	0	0	0	0	0	0

Primary outcome: Description of Electrocardiogram Findings

Time frame: Until 5-10 days after IMP administration. Count of participants. Unit: Participants

Measure	SAD Cohort 1 n = 6	SAD Cohort 2 n = 6	SAD Cohort 3 n = 6	SAD Cohort 4 n = 6	SAD Cohort 5 n = 6	SAD Placebo Cohort n = 10	SAD Food Interaction Sub-study n = 6	MAD Cohort 1 n = 9	MAD Cohort 2 n = 9	MAD Cohort 3 n = 9	MAD Placebo Cohort n = 9
Value	0	0	0	0	0	0	0	0	0	0	0

Primary outcome: Description of Vital Signs Findings

Time frame: Until 5-10 days after IMP administration. Count of participants. Unit: Participants

Measure	SAD Cohort 1 n = 6	SAD Cohort 2 n = 6	SAD Cohort 3 n = 6	SAD Cohort 4 n = 6	SAD Cohort 5 n = 6	SAD Placebo Cohort n = 10	SAD Food Interaction Sub-study n = 6	MAD Cohort 1 n = 9	MAD Cohort 2 n = 9	MAD Cohort 3 n = 9	MAD Placebo Cohort n = 9
Value	0	0	0	0	0	0	0	0	0	0	0

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first IMP administration until follow-up visit 5-10 days after last IMP administration. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SAD Cohort 1	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
SAD Cohort 2	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
SAD Cohort 3	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
SAD Cohort 4	0 of 6 (0%)	3 of 6 (50%)	0 of 6
SAD Cohort 5	0 of 6 (0%)	0 of 6 (0%)	0 of 6
SAD Placebo Cohort	0 of 10 (0%)	6 of 10 (60%)	0 of 10
SAD Food Interaction Sub-study	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
MAD Cohort 1	0 of 9 (0%)	7 of 9 (77.8%)	0 of 9
MAD Cohort 2	0 of 9 (0%)	8 of 9 (88.9%)	0 of 9
MAD Cohort 3	0 of 9 (0%)	4 of 9 (44.4%)	0 of 9
MAD Placebo Cohort	0 of 9 (0%)	8 of 9 (88.9%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Not Determined

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IRL757 in people with Not Determined, run by Integrative Research Laboratories AB at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of Frequency, Seriousness and Intensity of Adverse Events (time frame: Until 5-10 days after IMP administration). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06493045.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.