A Study of HY209 in Healthy Male Volunteers for Sepsis

• Status: Completed
• Trial end date: 2020-06-12
• Target enrollment: 0
• Participant gender: Male

Summary

A randomized, double-blind, placebo-controlled single dosing, dose escalation phase I clinical trial to investigate the safety/tolerability and pharmacokinetics of HY209 after intravenous administration in healthy male volunteers

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shaperon

Criteria

Inclusion Criteria:

• Healthy male aged from 19 to 45 at screening test

• BMI 18 kg/m2 ~ 27 kg/m2 at screening test

• Subjects found to be clinically healthy by medical history, physical examination, vital signs, electrocardiogram (ECG), and appropriate laboratory tests

• Those who must be capable of giving informed consent and willing to comply with all clinic visits and study-related procedures for the duration of study until study completion

Exclusion Criteria:

• Those who have a history of hypersensitivity or clinically significant hypersensitivity reactions to drugs (containing Taurodeoxycholate component, aspirin, antibiotics, etc.)

• Those who showed clinical symptoms suspected of acute infectious disease within 2 weeks before the first does, or whose body temperature (ear canal) measured at screening showed 38 ℃ or higher

• Those who have a clinically significant disease of liver, kidney, digestive, respiratory, endocrine, neurologic, blood/tumor, cardiovascular system history of those diseases

• Those who have a history of gastrointestinal diseases or surgery that may affect the absorption of the investigational drug

• Those who have a history of substance abuse or have tested positive for drugs of concern for misuse by urine drug screening

• Patients with the following blood pressure measured at the seat after resting for more than 5 minutes at the screening visit [Systolic blood pressure (SBP): < 90 mmHg or > 150 mmHg, Diastolic blood pressure (DBP): < 50 mmHg or > 90 mmHg]

• Those who participated in other clinical trials or bioequivalence within 6 months prior to the first dosing and received the drug

• Those who have donated whole blood within 2 months before the first dose or ingredient donation within 1 month or received blood transfusion within 1 month

• Those who have taken metabolic enzyme-induced and inhibitory drugs within 1 month before screening

• Those who consumed grapefruit / caffeine-containing foods within 3 days of the first dose and who cannot refrain from eating grapefruit-containing foods from 3 days before admission to discharge date

• Those who have taken specialty or herbal medicines within 2 weeks of the first dose or who have taken over-the-counter (OTC) within 1 week

• Caffeine overdose, alcohol overdose or oversmoker

• Those who have unusual eating habits or who are unable to eat the meals provided in this clinical trial

• Other investigator judged to be unsuitable as clinical subject