Study of MAR002 in Healthy Men
ConditionAcromegaly
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-40
SponsorMarea Therapeutics
About this trial
Evaluate the safety and tolerability of subcutaneous (SC) administration of MAR002 in healthy men
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Willingness to provide written informed consent
Age 18 to 40
Weight 55 to 95 kg
Body mass index (BMI) 18 to 30 kg/m2
Disqualifiers
History of hypersensitivity to monoclonal antibodies or study drug
Participation in any other investigational drug study
History of cancer
Recent acute illness
Trial design
Design model
Sequential
Treatments tested in this trial
MAR002
Drugsubcutaneous injection
Placebo
DrugSubcutaneous injection
Treatment groups
45 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Dose A MAR002Experimental treatment 2 interventions
Group B: Dose B MAR002Experimental treatment 2 interventions
Group C: Dose C MAR002Experimental treatment 2 interventions
Group D: Dose D MAR002Experimental treatment 2 interventions
Group E: Dose E MAR002Experimental treatment 2 interventions
Group F: Dose F MAR002Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of participants with TEAEs (treatment-emergent adverse events)
To evaluate the safety and tolerability of subcutaneous (SC) administration of MAR002 in healthy men
Time frame
From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.Secondary outcomes
1
PK Parameters -- Cmax
To evaluate the PK parameters through plasma concentration (Cmax)
Time frame
From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.2
PK Parameters - Tmax
To evaluate the PK parameters through plasma concentration (Tmax)
Time frame
From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.3
PK Parameters - AUC
To evaluate the PK parameters through plasma concentration (AUC)
Time frame
From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.4
PK Parameters - Half Life
To evaluate the PK parameters through plasma concentration (Half Life)
Time frame
From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov