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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: RLD2002; Drug: HCP1803-3; Drug: HCP1904-1

• Registration Number: NCT05723549
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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 available

Study Timeline

• Study Start: 2023-02-02
• Study First Submitted: 2023-02-02
• Study First Submitted QC: 2023-02-02
• Study First Posted: 2023-02-10
• Primary Completion: 2023-03-20
• Study Completion: 2023-03-20
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group2	RLD2002	Period1 : RLD2002, HCP1904-1
group2	HCP1904-1	Period1 : RLD2002, HCP1904-1
group1	HCP1803-3	Period1 : HCP1803-3

Primary Outcome Measures

Name	Time	Method
Cmax	0~144hours	pharmacokinetic evaluation
AUC last	0~144hours	pharmacokinetic evaluation

Secondary Outcome Measures

Name	Time	Method
t1/2	0~144hours	pharmacokinetic evaluation
CL/F	0~144hours	pharmacokinetic evaluation
AUC inf	0~144hours	pharmacokinetic evaluation
Tmax	0~144hours	pharmacokinetic evaluation
Vd/F	0~144hours	pharmacokinetic evaluation

Trial Locations

Locations (1)

Yangji Hospital; 🇰🇷 Seoul, Korea, Republic of