A Study to Evaluate the PK, Safety and Tolerability of HC... | NCT05723549

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

NCT05723549

Sponsor

Hanmi Pharmaceutical Company Limited

Status

Completed

Last Update Posted

Sep 22, 2023Actual

Enrollment

20Actual

Phase

Phase 1

Conditions

Healthy

Interventions

HCP1803-3
RLD2002
HCP1904-1

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2, 2023Actual

Primary Completion Date

Mar 20, 2023Actual

Completion Date

Mar 20, 2023Actual

First Submitted Date

Feb 2, 2023

First Submission Date that Met QC Criteria

Feb 2, 2023

First Posted Date

Feb 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2023

Last Update Posted Date

Sep 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group1	Experimental	Period1 : HCP1803-3	Drug: HCP1803-3
group2	Active Comparator	Period1 : RLD2002, HCP1904-1	Drug: RLD2002 Drug: HCP1904-1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HCP1803-3	Drug	Take it once per period	group1
RLD2002

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cmax	pharmacokinetic evaluation	0~144hours
AUC last	pharmacokinetic evaluation	0~144hours

Secondary Outcomes

Measure	Description	Time Frame
AUC inf	pharmacokinetic evaluation	0~144hours
Tmax	pharmacokinetic evaluation	0~144hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided