Safety and Tolerability Study With Multiple Ascending Doses of ORM-12741

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the safety and tolerability of escalating multiple doses of ORM-12741 in healthy volunteers

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Tolerability Study With Single Ascending Doses of ORM-12741

NCT00693316

Healthy

COMPLETED PHASE1

Safety and Pharmacokinetic Study With Multiple Ascending Doses of ORM-12741

NCT01068028

Healthy

COMPLETED PHASE1

Safety and Tolerability Study With Single Ascending Doses of ODM-102

NCT01839019

Healthy Volunteers

COMPLETED PHASE1

Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of OSE-127 in Healthy Subjects

NCT03980080

Healthy Subjects

COMPLETED PHASE1

A Dose-Escalation Study of RO7875913 in Healthy Participants

NCT07342114

Healthy Volunteers

NOT_YET_RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ORM-12741

Group Type EXPERIMENTAL

ORM-12741

Intervention Type DRUG

Alternating panel multiple dose escalation

Placebo

Group Type PLACEBO_COMPARATOR

ORM-12741

Intervention Type DRUG

Alternating panel multiple dose escalation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ORM-12741

Alternating panel multiple dose escalation

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Good general health ascertained by detailed medical history and physical examinations
* Males between 18 and 45 years
* Body mass index (BMI) between 18-30 kg/m2
* Weight 55-90 kg

Exclusion Criteria

* Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease
* Any condition requiring regular concomitant treatment including herbal products or likely to need any concomitant treatment during the study
* Susceptibility to severe allergic reactions
* Regular consumption of more than 14 units of alcohol per week
* Current use of nicotine-containing products more than 5 cigarettes or equivalent/day
* Inability to refrain from using nicotine-containing products during the stay in the study centre
* Inability to refrain from consuming caffeine-containing beverages during the stay in the study centre
* Blood donation or loss of significant amount of blood within 3 months prior to the screening visit
* Abnormal finding in ECG, vital signs, laboratory tests or physical examination
* Participation in a drug study within 3 months prior to the start of this study

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes