NCT05723549

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Feb 2023

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

February 2, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2023

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

February 2, 2023

Last Update Submit

September 20, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Cmax

    pharmacokinetic evaluation

    0~144hours

  • AUC last

    pharmacokinetic evaluation

    0~144hours

Secondary Outcomes (5)

  • AUC inf

    0~144hours

  • Tmax

    0~144hours

  • t1/2

    0~144hours

  • CL/F

    0~144hours

  • Vd/F

    0~144hours

Study Arms (2)

group1

EXPERIMENTAL

Period1 : HCP1803-3

Drug: HCP1803-3

group2

ACTIVE COMPARATOR

Period1 : RLD2002, HCP1904-1

Drug: RLD2002Drug: HCP1904-1

Interventions

HCP1803-3DRUG

Take it once per period

group1
RLD2002DRUG

Take it once per period

group2
HCP1904-1DRUG

Take it once per period

group2

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yangji Hospital

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2023

First Posted

February 10, 2023

Study Start

February 2, 2023

Primary Completion

March 20, 2023

Study Completion

March 20, 2023

Last Updated

September 22, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)