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

Sponsor

Hanmi Pharmaceutical Company Limited (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05723549

Collaborator

(none)

Enrollment

Location

Arms

1.2

Anticipated Duration (Months)

16.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: HCP1803-3 Drug: RLD2002 Drug: HCP1904-1	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized, Open-label, Single-Dose, Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1803 in Healthy Male Volunteers.

Anticipated Study Start Date :

Feb 3, 2023

Anticipated Primary Completion Date :

Mar 2, 2023

Anticipated Study Completion Date :

Mar 12, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: group1 Period1 : HCP1803-3	Drug: HCP1803-3 Take it once per period
Active Comparator: group2 Period1 : RLD2002, HCP1904-1	Drug: RLD2002 Take it once per period Drug: HCP1904-1 Take it once per period

Arm

Intervention/Treatment

Experimental: group1

Period1 : HCP1803-3

Drug: HCP1803-3

Take it once per period

Active Comparator: group2

Period1 : RLD2002, HCP1904-1

Drug: RLD2002

Take it once per period

Drug: HCP1904-1

Take it once per period

Outcome Measures

Primary Outcome Measures

Cmax [0~144hours]
pharmacokinetic evaluation
AUC last [0~144hours]
pharmacokinetic evaluation

Secondary Outcome Measures

AUC inf [0~144hours]
pharmacokinetic evaluation
Tmax [0~144hours]
pharmacokinetic evaluation
t1/2 [0~144hours]
pharmacokinetic evaluation
CL/F [0~144hours]
pharmacokinetic evaluation
Vd/F [0~144hours]
pharmacokinetic evaluation

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age 19~45 years in healthy male volunteers
Weight ≥ 55kg and BMI 18 ~ 30 kg/m^2
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.
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 system
Subjects who judged ineligible by the investigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yangji Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Hanmi Pharmaceutical Company Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hanmi Pharmaceutical Company Limited

ClinicalTrials.gov Identifier:

NCT05723549

Other Study ID Numbers:

HM-APOLLO-101

First Posted:

Feb 10, 2023

Last Update Posted:

Feb 13, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 13, 2023