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Study to Evaluate LPH-5 in Healthy Subjects

NCT ID: NCT06722820

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2025-12-31

Brief Summary

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This study will explore the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of LPH-5.

Detailed Description

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Conditions

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Safety Issues Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

LPH-5\_dose 1, single dose

Group Type EXPERIMENTAL

LPH-5

Intervention Type DRUG

LPH-5

Placebo

Intervention Type DRUG

Placebo

Cohort 2

LPH-5\_dose 2, single dose

Group Type EXPERIMENTAL

LPH-5

Intervention Type DRUG

LPH-5

Placebo

Intervention Type DRUG

Placebo

Cohort 3

LPH-5\_dose 3, single dose

Group Type EXPERIMENTAL

LPH-5

Intervention Type DRUG

LPH-5

Placebo

Intervention Type DRUG

Placebo

Cohort 4

LPH-5\_dose 4, single dose

Group Type EXPERIMENTAL

LPH-5

Intervention Type DRUG

LPH-5

Placebo

Intervention Type DRUG

Placebo

Cohort 5

LPH-5\_dose 5, single dose

Group Type EXPERIMENTAL

LPH-5

Intervention Type DRUG

LPH-5

Placebo

Intervention Type DRUG

Placebo

Cohort 6

LPH-5\_dose 6, single dose

Group Type EXPERIMENTAL

LPH-5

Intervention Type DRUG

LPH-5

Placebo

Intervention Type DRUG

Placebo

Interventions

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LPH-5

LPH-5

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Biotrial

INDUSTRY

Sponsor Role collaborator

Lophora

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sophie Hays, MD

Role: PRINCIPAL_INVESTIGATOR

Biotrial

Central Contacts

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Mikael Thomsen, PhD

Role: CONTACT

Phone: 23276134

Email: [email protected]

Jesper Kristensen, PhD

Role: CONTACT

Phone: 25709521

Email: [email protected]

Other Identifiers

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LPH-5CS01

Identifier Type: -

Identifier Source: org_study_id