A First-in-Human, Single- and Multiple-Ascending Dose Study of YH35995 in Healthy Adult Male Participants

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age19-45
SponsorYuhan Corporation

About this trial

This is a randomized, double-blind, first-in-human study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple oral doses of YH35995

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male between the ages of 19 and 45 at the time of providing written consent

Participants who weigh at least 50 kg at screening and have a body mass index (BMI) of at least 18.0 kg/m2 and less than 30 kg/m2

Participants who have been fully informed about and fully understand this study, have voluntarily decided to participate, and have agreed in writing to comply with the guidelines of the study during the duration of the study

Disqualifiers

Participation in a bioequivalence trial or any other clinical trials within 6 months prior to the first scheduled dose of the IP (within 1 month of the first scheduled dose for participants who have taken part in a dietary supplement clinical trial)

Individuals with clinically significant abnormal results that do not match any other inclusion/exclusion criteria, as determined by the principal investigator and the delegated persons(investigator)

Individuals who are unwilling or unable to comply with the participant guidelines described in this protocol

Trial design

Design model

Parallel

Treatments tested in this trial

  • YH35995

    Drug

    Oral administration of YH35995

  • Placebo

    Drug

    Oral administration of Placebo

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: YH35995Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

[Part A, B] Treatment-emergent adverse events (TEAEs)

To assess the safety and tolerability of a single dose and multiple dose administration of YH35995

Time frame
Part A: Day1-150, Part B: Day1-232

Secondary outcomes

1

[Part A] Maximum observed plasma concentration (Cmax)

To characterize the pharmacokinetics (PK) of YH35995

Time frame
Day1-150
2

[Part A] Time to reach Cmax (Tmax)

To characterize the pharmacokinetics (PK) of YH35995

Time frame
Day1-150
3

[Part A] Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)

To characterize the pharmacokinetics (PK) of YH35995

Time frame
Day1-150
4

[Part A] AUC from time 0 to infinity (AUCinf)

To characterize the pharmacokinetics (PK) of YH35995

Time frame
Day1-150

Other outcomes

Sponsors and contacts

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