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A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.

Hanmi Pharmaceutical logo

Hanmi Pharmaceutical

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: HCP1904-1
Drug: HCP1904-3

Study type

Interventional

Funder types

Industry

Identifiers

NCT05407220
HM-CHORUS-102

Details and patient eligibility

About

A Randomized, Open-Label, Single-Dose Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.

Enrollment

16 patients

Sex

Male

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

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 medically accepted dual contraceptives up to 14 days after the last administration date of the clinical trial drug 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

16 participants in 2 patient groups

group1
Experimental group
Description:
Period1: HCP1904-1
Treatment:
Drug: HCP1904-1
group2
Experimental group
Description:
Period1: HCP1904-3
Treatment:
Drug: HCP1904-3

Trial contacts and locations

1

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Central trial contact

Jina Jung, PhD; Jaewoo Kim

Data sourced from clinicaltrials.gov

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