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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05723549
• Other study ID #: HM-APOLLO-101
• Status: Completed
• Phase: Phase 1
• Start date: February 2, 2023
• Est. completion date: March 20, 2023

Study information

• Verified date: September 2023
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 20, 2023
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• HCP1803-3
Take it once per period
• RLD2002
Take it once per period
• HCP1904-1
Take it once per period

Locations

Country	Name	City	State
Korea, Republic of	Yangji Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	pharmacokinetic evaluation	0~144hours
Primary	AUC last	pharmacokinetic evaluation	0~144hours
Secondary	AUC inf	pharmacokinetic evaluation	0~144hours
Secondary	Tmax	pharmacokinetic evaluation	0~144hours
Secondary	t1/2	pharmacokinetic evaluation	0~144hours
Secondary	CL/F	pharmacokinetic evaluation	0~144hours
Secondary	Vd/F	pharmacokinetic evaluation	0~144hours