A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of WIF-2402 in Healthy Adults (WIF-2401-101)
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 WIF-2402 in Healthy Male Adult Volunteers
What is this study about? This is a Phase 1 study, which means it is one of the first times WIF-2402 is being tested in people. The study includes only healthy adult men.
What are we trying to learn?
Safety and tolerability: Does the drug cause side effects, and how well do people handle it? How the body handles the drug (pharmacokinetics): How the drug is absorbed, how it moves through the body, and how it leaves the body.
What the drug does to the body (pharmacodynamics): What effects the drug has on the body.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 1
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Healthy men aged 19 to 50 years
- Body weight 50.0 to 90.0 kg and BMI 18.5 to 29.9 kg/m2
- Willing to sign a written informed consent form
Exclusion Criteria:
- Any clinically significant disease or abnormal screening test result
- Allergy to the study drug or related drugs
- Use of other medicines or participation in another clinical trial shortly before the study
- Heavy drinking, smoking, or drug abuse
- Judged by the investigator to be unsuitable for the study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: WIF-2402ESO
|
An approved medicine used as an active comparator. |
|
Placebo komparator: WIF-2402Placebo
|
A placebo that looks the same as WIF-2402 but contains no active drug. |
|
Eksperimentel: WIF-2402
|
WIF-2402 will be given by mouth as a single dose or multiple doses, with the dose increased step by step |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
Tidsramme: (SAD) From first dose (Day 1) up to 7-9 days after the last dose/Safety (MAD) From first dose (Day 1) up to 13-15 days after the last dose (Day 7)
|
(SAD) From first dose (Day 1) up to 7-9 days after the last dose/Safety (MAD) From first dose (Day 1) up to 13-15 days after the last dose (Day 7)
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- WIF-2402-101
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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