A Study to Evaluate the PK, Safety and Tolerability of HCP1803.

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: HCP1803-3; Drug: HCP1904-1; Drug: RLD2002

Study type: Interventional

Funder types: Industry

Identifiers

NCT05723549

HM-APOLLO-101

Details and patient eligibility

About

A randomized, open-label, single-dose parallel study to evaluate the pharmacokinetics, safety and tolerability of HCP1803 in healthy male volunteers.

Enrollment: 20 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 19~45 years in healthy male volunteers
2. Weight ≥ 55kg and BMI 18 ~ 30 kg/m^2
3. Subjects 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.
4. 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

1. 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 system
2. Subjects who judged ineligible by the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

group1

Experimental group

Description:

Period1 : HCP1803-3

Treatment:

Drug: HCP1803-3

group2

Active Comparator group

Description:

Period1 : RLD2002, HCP1904-1

Treatment:

Drug: RLD2002

Drug: HCP1904-1