Health TrialsbyHealthPanel

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of IY-828026 in Healthy Volunteers

ConditionHealhty
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-50
SponsorIl-Yang Pharm. Co., Ltd.

About this trial

A randomized, double-blinded, partial-open, placebo/active-controlled, single/multiple dosing, dose escalation phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic characteristics of IY-828026 in healthy adult volunteers

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy adult volunteers aged ≥ 19 and ≤ 50 years at screening

Body weight ≥ 50.0 kg to ≤ 90.0 kg and body mass index (BMI) of ≥ 18.5 kg/m2 to ≤ 29.9 kg/m2 at screening

Volunteers who were fully informed of and completely understood this study, voluntarily agreed to participate, and provided written consent to comply with the precautions

Disqualifiers

Current or history of clinically significant disease of hepatobiliary (severe hepatic impairment, viral hepatitis, etc.), renal (severe renal impairment, etc.), nervous, immune, respiratory, gastrointestinal, endocrine, hemato-oncologic, cardiovascular (heart failure, torsades de pointes, etc.), urinary, or psychiatric (mood disorder, obsessive compulsory disorder, etc.) system or sexual dysfunctions

H. pylori eradication treatment within 6 months or positive result for H. pylori at screening

Hypersensitivity or history of clinically significant hypersensitivity to PPIs, P-CABs, and other drugs (aspirin, antibiotics, etc.)

A positive result in serology (hepatitis B tests, hepatitis C tests, human immunodeficiency virus [HIV] tests, or syphilis tests)

Trial design

Design model

Parallel

Treatments tested in this trial

  • IY-828026

    Drug

    IY-828026

  • Placebo

    Drug

    Placebo comparator

  • IY-828026A

    Drug

    Active comparator

  • IY-828026B

    Drug

    Active comparator

Treatment groups

86 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: (SAD) IY-828026 10 mgExperimental treatment 2 interventions
Group B: (SAD) IY-828026 20 mgExperimental treatment 2 interventions
Group C: (SAD) IY-828026 40 mgExperimental treatment 2 interventions
Group D: (SAD) IY-828026 80 mgExperimental treatment 2 interventions
Group E: (SAD) IY-828026 160 mgExperimental treatment 2 interventions
Group F: (MAD) IY-828026 20 mgExperimental treatment 2 interventions
Group G: (MAD) IY-828026 40 mgExperimental treatment 2 interventions
Group H: (MAD) IY-828026 80 mgExperimental treatment 2 interventions
Group I: (MAD) IY-828026AActive comparator 1 intervention
Group J: (MAD) IY-828026BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants With Adverse Events

All adverse events occurring during the clinical trial following a single or multiple ascending dose of IY-828026 will be collected and evaluated for seriousness, severity, and their relationship to the investigational product. Events will be coded using MedDRA System Organ Class and Preferred Term. \[Unit of Measure\] Participants

Time frame
Approximately Day 9 for SAD and Day 15 for MAD
2

Pharmacokinetic Parameters: Maximum Plasma Concentration (Cmax) (SAD)

Cmax will be determined using non-compartmental analysis following a single ascending dose of IY-828026 \[Unit of Measure\] ng/mL

Time frame
Day 1 pre-dose (0hour), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hour (Day 2), 48 hour (Day 3), and 72hour (Day 4) post-dose
3

Pharmacokinetic Parameters: Area Under the Concentration-Time Curve (AUC₀-last) (SAD)

AUC₀-t will be calculated using non-compartmental analysis following a single ascending dose of IY-828026 \[Unit of Measure\] ng·h/mL

Time frame
Day 1 pre-dose (0hour), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hour (Day 2), 48 hour (Day 3), and 72hour (Day 4) post-dose
4

Pharmacokinetic Parameters: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUCinf) (SAD)

AUCinf will be calculated from the concentration-time curve following a single ascending dose of IY-828026 \[Unit of Measure\] ng·h/mL

Time frame
Day 1 pre-dose (0hour), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hour (Day 2), 48 hour (Day 3), and 72hour (Day 4) post-dose

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Il-Yang Pharm. Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now