Safety IssuesPhase 1NCT06722820
Study to Evaluate LPH-5 in Healthy Subjects
A Phase 1 study testing LPH-5 in people with Safety Issues and Tolerance, run by Lophora.
Trial summary
This study will explore the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of LPH-5. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Safety Issues, Tolerance
- What is being tested?
- LPH-5
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2025to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examination, concomitant medication, vital signs, 12-lead ECG, and clinical laboratory evaluations.
Who cannot join
- Any condition or disease detected during the medical interview/physical examination that could relapse during or immediately after the study, or would render the participant unsuitable for the study, place the participant at undue risk, or interfere with the ability of the participant to complete the clinical study, as determined by the Investigator.
- Have a history of and/or current clinically significant determined by the Investigator
- Consumes cannabis or cannabis-derived compounds more than 3 times per month or has substantial changes in cannabis consumption in the 21 days prior to screening.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase I, First-in-man, Randomised, Placebo-controlled, Single Dose Escalation Study to Investigate the Effects of LPH-5 on Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Parameters in Healthy Participants
This study will explore the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of LPH-5.
- Conditions
- Safety Issues, Tolerance
- Being tested
- LPH-5, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPH-5Drug
LPH-5
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | LPH-5_dose 1, single dose Receives: Drug: LPH-5; Drug: Placebo |
| Cohort 2 | Experimental | LPH-5_dose 2, single dose Receives: Drug: LPH-5; Drug: Placebo |
| Cohort 3 | Experimental | LPH-5_dose 3, single dose Receives: Drug: LPH-5; Drug: Placebo |
| Cohort 4 | Experimental | LPH-5_dose 4, single dose Receives: Drug: LPH-5; Drug: Placebo |
| Cohort 5 | Experimental | LPH-5_dose 5, single dose Receives: Drug: LPH-5; Drug: Placebo |
| Cohort 6 | Experimental | LPH-5_dose 6, single dose Receives: Drug: LPH-5; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs)
Measured: Through study completion, an average of 1 year
Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results
Measured: Through study completion, an average of 1 year
Incidence of abnormal clinical laboratory findings in 12-lead ECG parameters, vital signs, and physical examination
Measured: Through study completion, an average of 1 year
Secondary outcomes (9)
Pharmacokinetics parameters - Cmax
Plasma PK concentrations including but not limited to: maximum plasma concentration (Cmax) (ng/ml)
Measured: Time Frame: 0-48 hours
Pharmacokinetics parameters - tmax
Plasma PK concentrations including but not limited to: time to reach Cmax (tmax) (minutes)
Measured: Time Frame: 0-48 hours
Pharmacokinetics parameters - AUC0-t
Plasma PK concentrations including but not limited to: area under the plasma concentration-time curve (AUC) from zero to the last quantifiable concentration (AUC0-t) (ng/ml x hours)
Measured: Time Frame: 0-48 hours
Pharmacokinetics parameters - AUC0-∞
Plasma PK concentrations including but not limited to: AUC from zero to infinity (AUC0-∞)(ng/ml x hours)
Measured: Time Frame: 0-48 hours
Pharmacokinetics parameters - AUC0-24h
Plasma PK concentrations including but not limited to: AUC from zero to 24 hours (AUC0-24h) (ng/ml x hours)
Measured: Time Frame: 0-48 hours
Pharmacokinetics parameters - AUC0-48h
Plasma PK concentrations including but not limited to: AUC from zero to 48 hours (AUC0-48h) (ng/ml x hours)
Measured: Time Frame: 0-48 hours
Pharmacokinetics parameters - half life
Plasma PK concentrations including but not limited to: half life (t1/2) (hours)
Measured: Time Frame: 0-48 hours
Pharmacodynamic parameter - assessing the mood and subjective effects of single ascending doses of LPH-5 in healthy participants in questionnaires
Measured: Time Frame: 0-48 hours
Pharmacodynamic parameter - Pharmaco-EEG (qEEG)
Power spectral analysis of absolute and/or relative amplitude in the various frequency bands.
Measured: Time Frame: 0-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start30 Apr 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lophora
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biotrial
- Responsible party
- Sponsor
- Investigators
- Sophie Hays, MD, Principal investigator, Biotrial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722820
- Sponsor's protocol ID
- LPH-5CS01
- Status last verified
- Dec 2024
- First submitted
- 19 Nov 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, First-in-man, Randomised, Placebo-controlled, Single Dose Escalation Study to Investigate the Effects of LPH-5 on Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Parameters in Healthy Participants
- ClinicalTrials.gov ID
- NCT06722820
- Acronym / sponsor ID
- LPH-5CS01
- Conditions
- Safety Issues, Tolerance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- LophoraIndustry (pharma, biotech, devices)
- Collaborators
- Biotrial
- Study start
- 30 Apr 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Dec 2024 (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.
This study will explore the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of LPH-5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: LPH-5, Drug: PlaceboLPH-5_dose 1, single dose |
| Cohort 2 | Experimental | Drug: LPH-5, Drug: PlaceboLPH-5_dose 2, single dose |
| Cohort 3 | Experimental | Drug: LPH-5, Drug: PlaceboLPH-5_dose 3, single dose |
| Cohort 4 | Experimental | Drug: LPH-5, Drug: PlaceboLPH-5_dose 4, single dose |
| Cohort 5 | Experimental | Drug: LPH-5, Drug: PlaceboLPH-5_dose 5, single dose |
| Cohort 6 | Experimental | Drug: LPH-5, Drug: PlaceboLPH-5_dose 6, single dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examination, concomitant medication, vital signs, 12-lead ECG, and clinical laboratory evaluations.
Key exclusion criteria (3 listed)
- Any condition or disease detected during the medical interview/physical examination that could relapse during or immediately after the study, or would render the participant unsuitable for the study, place the participant at undue risk, or interfere with the ability of the participant to complete the clinical study, as determined by the Investigator.
- Have a history of and/or current clinically significant determined by the Investigator
- Consumes cannabis or cannabis-derived compounds more than 3 times per month or has substantial changes in cannabis consumption in the 21 days prior to screening.
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 |
|---|---|---|
| LPH-5LPH-5 | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
| PlaceboPlacebo | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
Primary outcome
Incidence and severity of adverse events (AEs)
Time frame: Through study completion, an average of 1 year
Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results
Time frame: Through study completion, an average of 1 year
Incidence of abnormal clinical laboratory findings in 12-lead ECG parameters, vital signs, and physical examination
Time frame: Through study completion, an average of 1 year
9 secondary outcomes
Pharmacokinetics parameters - Cmax
Time frame: Time Frame: 0-48 hours
Pharmacokinetics parameters - tmax
Time frame: Time Frame: 0-48 hours
Pharmacokinetics parameters - AUC0-t
Time frame: Time Frame: 0-48 hours
Pharmacokinetics parameters - AUC0-∞
Time frame: Time Frame: 0-48 hours
Pharmacokinetics parameters - AUC0-24h
Time frame: Time Frame: 0-48 hours
Pharmacokinetics parameters - AUC0-48h
Time frame: Time Frame: 0-48 hours
Pharmacokinetics parameters - half life
Time frame: Time Frame: 0-48 hours
Pharmacodynamic parameter - assessing the mood and subjective effects of single ascending doses of LPH-5 in healthy participants in questionnaires
Time frame: Time Frame: 0-48 hours
Pharmacodynamic parameter - Pharmaco-EEG (qEEG)
Time frame: Time Frame: 0-48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
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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.
Sophie Hays, MD principal investigator
Biotrial
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LPH-5 in people with Safety Issues and Tolerance, run by Lophora.
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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mikael Thomsen, PhD (23276134, mik.thomsen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. 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 9 Dec 2024.