HealthyPhase 1NCT05682352
Investigating the Safety of LEO 158968 in Healthy Volunteers
A Phase 1 study testing LEO 158968 in people with Healthy, run by LEO Pharma at 1 site in Netherlands.
Trial summary
The purpose of this study is to investigate what side effects the new compound LEO 158968 might cause and how well it is tolerated when it is used by healthy participants. It will also investigate how quickly and to what extent LEO 158968 is distributed and eliminated from the body and if LEO 158968 causes the body to… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LEO 158968
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Feb 2023to 1 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 to 60 years, inclusive, at screening
- Sex: Male or female
- Body mass index: 18.0 kg/m^2 to 32.0 kg/m^2, inclusive, at screening
- Health status: In good health as judged by the Investigator based on medical history, physical examination, electrocardiogram (ECG), hematology, biochemistry, and urinalysis.
Who cannot join
- A participant who meets any of the following exclusion criteria will not be eligible for inclusion in the study:
- Male participants sexually active with a woman of childbearing potential who are not willing to use a barrier method of contraception (eg, condom) from the time of first dose of investigational medicinal product (IMP) until 16 weeks after the last dose, in conjunction with this female partner using a highly effective form of contraception.
- Female participants who are pregnant, lactating, or planning to become pregnant during the time of the trial.
- Participants with any surgical or medical condition which might significantly alter the distribution, metabolism, or excretion of any drug.
- Positive polymerase chain reaction (PCR) test for coronavirus disease-19 (COVID-19) on Day -1, or contact with COVID-19 positive (or suspected) persons within 14 days prior to first dose.
- ECG with QT-interval corrected for heart rate (QTc) using Fridericia's formula (QTcF) >450 msec for men, >460 msec for women, confirmed by repeat measurement at screening.
- Treatment with any prescribed or nonprescribed systemic or topical medication within 7 days prior to the first dose of IMP (excluding paracetamol; including herbal remedies), unless, in the opinion of the Investigator and the Sponsor, the medication will not interfere with the trial procedures or compromise safety.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single- And Multiple Ascending Dose Trial To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Leo 158968 In Healthy Subjects
The purpose of this study is to investigate what side effects the new compound LEO 158968 might cause and how well it is tolerated when it is used by healthy participants. It will also investigate how quickly and to what extent LEO 158968 is distributed and eliminated from the body and if LEO 158968 causes the body to make antibodies.
In the single ascending dose (SAD) cohorts, participants will receive escalating doses of LEO 158968 if the safety and tolerability results of the initial participants up to 48 hours (or 4 days for SC dosing) following dosing are acceptable to the Investigator.
In the multiple ascending dose (MAD) cohorts, the dose of LEO 158968 will be determined based on results derived from the earlier SAD cohorts and additional preclinical data from a 5-week good laboratory practice (GLP) cynomolgus monkey toxicology study.
- Conditions
- Healthy
- Being tested
- LEO 158968, Placebo
- Keywords
- Healthy Volunteers, LEO 158968
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 158968Drug
IV infusion or SC injection
PlaceboDrug
IV infusion or SC injection
LEO 158968Drug
SC injection
PlaceboDrug
SC injection
| Study group | Role | What they receive |
|---|---|---|
| LEO 158968 Single Ascending Dose (SAD) Cohorts | Experimental | Participants will receive a single dose of LEO 158968 or matching placebo via an intravenous (IV) infusion or subcutaneous (SC) injection. The dose of LEO 158968 will be increased per cohort. Receives: Drug: LEO 158968; Drug: Placebo |
| LEO 158968 Multiple Ascending Dose (MAD) Cohorts | Experimental | Participants will receive 5 once weekly (QW) doses of LEO 158968 or matching placebo via a SC injection. Receives: Drug: LEO 158968; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment-emergent Adverse Events (TEAEs) Reported for Each Participant
Any clinically significant changes from baseline in clinical laboratory parameters, vital signs including systolic and diastolic blood pressure, and abnormal clinically significant findings from physical examinations following first dose will be recorded as TEAEs.
Measured: Day 1 to Day 113
Secondary outcomes (16)
Area Under the Serum Concentration-time Curve from Time 0 to Infinity (AUC0-∞) of LEO 158968
Measured: Day 1 to Day 85
Area Under the Serum Concentration-time Curve from 0 Hours to 168 Hours (AUC0-168h) of LEO 158968
Measured: Day 1 to Day 85
Area Under the Serum Concentration-time Curve from t=0 to t (AUC0-t) of LEO 158968
Where t corresponds to the last observed quantifiable concentration calculated by the linear up - logarithmic down trapezoidal rule.
Measured: Day 1 to Day 85
Serum Concentration Observed at 168 Hours Post-dose (C168h) of LEO 158968
Measured: Day 1 to Day 85
Maximum Observed Serum Concentration (Cmax) of LEO 158968
Measured: Day 1 to Day 85
Apparent Terminal Half-life (t1/2) of LEO 158968
Measured: Day 1 to Day 85
Time of Last Quantifiable Concentration (tlast) of LEO 158968
Measured: Day 1 to Day 85
Time of Cmax (tmax) of LEO 158968
Measured: Day 1 to Day 85
Area Under the Serum Concentration-time Curve Over the Dosing Interval τ (ie, 168 hours) (AUCτ) of LEO 158968
Measured: Day 1 to Day 113
AUC0-t of LEO 158968
Measured: Day 1 to Day 113
Trough Serum Concentration Observed at the End of a Dosing Interval (168 hours post-dose) (Cτ) of LEO 158968
Measured: Day 1 to Day 113
Cmax of LEO 158968
Measured: Day 1 to Day 113
t1/2 of LEO 158968
Measured: Day 1 to Day 113
tlast of LEO 158968
Measured: Day 1 to Day 113
tmax of LEO 158968
Measured: Day 1 to Day 113
Number of Participants with Antidrug Antibodies (ADA)
Measured: Day 1 to Day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start7 Feb 2023
- Primary completion7 May 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682352
- Sponsor's protocol ID
- LP0189-2242
- Other IDs
- 2022-002768-65, U1111-1285-9850
- Status last verified
- Apr 2025
- First submitted
- 4 Jan 2023
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single- And Multiple Ascending Dose Trial To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Leo 158968 In Healthy Subjects
- ClinicalTrials.gov ID
- NCT05682352
- Acronym / sponsor ID
- LP0189-2242
- Conditions
- Healthy
- Keywords
- Healthy Volunteers, LEO 158968
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate what side effects the new compound LEO 158968 might cause and how well it is tolerated when it is used by healthy participants. It will also investigate how quickly and to what extent LEO 158968 is distributed and eliminated from the body and if LEO 158968 causes the body to make antibodies.
In the single ascending dose (SAD) cohorts, participants will receive escalating doses of LEO 158968 if the safety and tolerability results of the initial participants up to 48 hours (or 4 days for SC dosing) following dosing are acceptable to the Investigator.
In the multiple ascending dose (MAD) cohorts, the dose of LEO 158968 will be determined based on results derived from the earlier SAD cohorts and additional preclinical data from a 5-week good laboratory practice (GLP) cynomolgus monkey toxicology study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEO 158968 Single Ascending Dose (SAD) Cohorts | Experimental | Drug: LEO 158968, Drug: PlaceboParticipants will receive a single dose of LEO 158968 or matching placebo via an intravenous (IV) infusion or subcutaneous (SC) injection. The dose of LEO 158968 will be increased per cohort. |
| LEO 158968 Multiple Ascending Dose (MAD) Cohorts | Experimental | Drug: LEO 158968, Drug: PlaceboParticipants will receive 5 once weekly (QW) doses of LEO 158968 or matching placebo via a SC injection. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 18 to 60 years, inclusive, at screening
- Sex: Male or female
- Body mass index: 18.0 kg/m^2 to 32.0 kg/m^2, inclusive, at screening
- Health status: In good health as judged by the Investigator based on medical history, physical examination, electrocardiogram (ECG), hematology, biochemistry, and urinalysis.
Key exclusion criteria (7 listed)
- A participant who meets any of the following exclusion criteria will not be eligible for inclusion in the study:
- Male participants sexually active with a woman of childbearing potential who are not willing to use a barrier method of contraception (eg, condom) from the time of first dose of investigational medicinal product (IMP) until 16 weeks after the last dose, in conjunction with this female partner using a highly effective form of contraception.
- Female participants who are pregnant, lactating, or planning to become pregnant during the time of the trial.
- Participants with any surgical or medical condition which might significantly alter the distribution, metabolism, or excretion of any drug.
- Positive polymerase chain reaction (PCR) test for coronavirus disease-19 (COVID-19) on Day -1, or contact with COVID-19 positive (or suspected) persons within 14 days prior to first dose.
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 |
|---|---|---|
| LEO 158968IV infusion or SC injection | Drug | LEO 158968 Single Ascending Dose (SAD) Cohorts |
| PlaceboIV infusion or SC injection | Drug | LEO 158968 Single Ascending Dose (SAD) Cohorts |
| LEO 158968SC injection | Drug | LEO 158968 Multiple Ascending Dose (MAD) Cohorts |
| PlaceboSC injection | Drug | LEO 158968 Multiple Ascending Dose (MAD) Cohorts |
Primary outcome
Number of Treatment-emergent Adverse Events (TEAEs) Reported for Each Participant
Time frame: Day 1 to Day 113
Any clinically significant changes from baseline in clinical laboratory parameters, vital signs including systolic and diastolic blood pressure, and abnormal clinically significant findings from physical examinations following first dose will be recorded as TEAEs.
16 secondary outcomes
Area Under the Serum Concentration-time Curve from Time 0 to Infinity (AUC0-∞) of LEO 158968
Time frame: Day 1 to Day 85
Area Under the Serum Concentration-time Curve from 0 Hours to 168 Hours (AUC0-168h) of LEO 158968
Time frame: Day 1 to Day 85
Area Under the Serum Concentration-time Curve from t=0 to t (AUC0-t) of LEO 158968
Time frame: Day 1 to Day 85
Serum Concentration Observed at 168 Hours Post-dose (C168h) of LEO 158968
Time frame: Day 1 to Day 85
Maximum Observed Serum Concentration (Cmax) of LEO 158968
Time frame: Day 1 to Day 85
Apparent Terminal Half-life (t1/2) of LEO 158968
Time frame: Day 1 to Day 85
Time of Last Quantifiable Concentration (tlast) of LEO 158968
Time frame: Day 1 to Day 85
Time of Cmax (tmax) of LEO 158968
Time frame: Day 1 to Day 85
Area Under the Serum Concentration-time Curve Over the Dosing Interval τ (ie, 168 hours) (AUCτ) of LEO 158968
Time frame: Day 1 to Day 113
AUC0-t of LEO 158968
Time frame: Day 1 to Day 113
Trough Serum Concentration Observed at the End of a Dosing Interval (168 hours post-dose) (Cτ) of LEO 158968
Time frame: Day 1 to Day 113
Cmax of LEO 158968
Time frame: Day 1 to Day 113
t1/2 of LEO 158968
Time frame: Day 1 to Day 113
tlast of LEO 158968
Time frame: Day 1 to Day 113
tmax of LEO 158968
Time frame: Day 1 to Day 113
Number of Participants with Antidrug Antibodies (ADA)
Time frame: Day 1 to Day 113
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Medical Expert study director
LEO Pharma
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 LEO 158968 in people with Healthy, run by LEO Pharma at 1 site in Netherlands.
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 7 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 28 Apr 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 Netherlands. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Treatment-emergent Adverse Events (TEAEs) Reported for Each Participant (time frame: Day 1 to Day 113). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2026.