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NCT05723549
A Study to Evaluate the PK, Safety and Tolerability of HCP1803.
Conditions: Healthy
Sex: Male
Ages: 19 Years – 45 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 20
Sponsor: Hanmi Pharmaceutical Company Limited
Location: Korea, Republic of
Summary
A randomized, open-label, single-dose parallel study to evaluate the pharmacokinetics, safety and tolerability of HCP1803 in healthy male volunteers.
Eligibility Criteria
Inclusion Criteria:Age 19~45 years in healthy male volunteersWeight ≥ 55kg and BMI 18 ~ 30 kg/m^2Subjects who agree to use clinically accepted dual contraceptives up to 14 days after the last administration date of the investigational product and not to provide sperm.Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing.Exclusion Criteria:Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular systemSubjects who judged ineligible by the investigator
Source: ClinicalTrials.gov (NCT05723549). StuddyBuddy aggregates publicly available trial information.