Investigating the Safety of LEO 158968 in Healthy Volunteers

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05682352
• Other study ID #: LP0189-2242
• Secondary ID: 2022-002768-65U1
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: February 7, 2023
• Est. completion date: July 2024

Study information

• Verified date: May 2024
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: July 2024
• Est. primary completion date: May 7, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Age: 18 to 60 years, inclusive, at screening

2. Sex: Male or female

3. Body mass index: 18.0 kg/m^2 to 32.0 kg/m^2, inclusive, at screening

4. Health status: In good health as judged by the Investigator based on medical history, physical examination, electrocardiogram (ECG), hematology, biochemistry, and urinalysis.

Exclusion Criteria:

A participant who meets any of the following exclusion criteria will not be eligible for inclusion in the study:

1. 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.

2. Female participants who are pregnant, lactating, or planning to become pregnant during the time of the trial.

3. Participants with any surgical or medical condition which might significantly alter the distribution, metabolism, or excretion of any drug.

4. 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.

5. 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.

6. 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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• LEO 158968
IV infusion or SC injection
• Placebo
IV infusion or SC injection
• LEO 158968
SC injection
• Placebo
SC injection

Locations

Country	Name	City	State
Netherlands	LEO Pharma Investigational Site	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1 to Day 113
Secondary	Area Under the Serum Concentration-time Curve from Time 0 to Infinity (AUC0-8) of LEO 158968		Day 1 to Day 85
Secondary	Area Under the Serum Concentration-time Curve from 0 Hours to 168 Hours (AUC0-168h) of LEO 158968		Day 1 to Day 85
Secondary	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.	Day 1 to Day 85
Secondary	Serum Concentration Observed at 168 Hours Post-dose (C168h) of LEO 158968		Day 1 to Day 85
Secondary	Maximum Observed Serum Concentration (Cmax) of LEO 158968		Day 1 to Day 85
Secondary	Apparent Terminal Half-life (t1/2) of LEO 158968		Day 1 to Day 85
Secondary	Time of Last Quantifiable Concentration (tlast) of LEO 158968		Day 1 to Day 85
Secondary	Time of Cmax (tmax) of LEO 158968		Day 1 to Day 85
Secondary	Area Under the Serum Concentration-time Curve Over the Dosing Interval t (ie, 168 hours) (AUCt) of LEO 158968		Day 1 to Day 113
Secondary	AUC0-t of LEO 158968		Day 1 to Day 113
Secondary	Trough Serum Concentration Observed at the End of a Dosing Interval (168 hours post-dose) (Ct) of LEO 158968		Day 1 to Day 113
Secondary	Cmax of LEO 158968		Day 1 to Day 113
Secondary	t1/2 of LEO 158968		Day 1 to Day 113
Secondary	tlast of LEO 158968		Day 1 to Day 113
Secondary	tmax of LEO 158968		Day 1 to Day 113
Secondary	Number of Participants with Antidrug Antibodies (ADA)		Day 1 to Day 113