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- Klinische proef NCT07570147
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Ascending Doses of ABBV-1451 Infusions and Injections in Healthy Adult Participants
A First in Human, Single Ascending Dose Study of ABBV-1451 to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability in Healthy Subjects and in Japanese and Han Chinese Healthy Subjects
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 1
Contacten en locaties
Studiecontact
- Naam: ABBVIE CALL CENTER
- Telefoonnummer: 844-663-3742
- E-mail: abbvieclinicaltrials@abbvie.com
Studie Locaties
-
-
Illinois
-
Grayslake, Illinois, Verenigde Staten, 60030
- Werving
- Acpru /Id# 282128
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
- Applies to Part 2 only:
For Japanese participants:
-- Participant must be first or second-generation Japanese of full Japanese parentage, residing outside of Japan. First generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. Participants must be in general good health.
For Han Chinese participants:
- Participant must be first or second-generation Han Chinese of full Chinese parentage, residing outside of China. First generation participants will have been born in China to two parents and four grandparents also born in China of full Chinese descent. Second-generation participants born outside of China must have two parents and four grandparents born in China of full Chinese descent. Participants must be in general good health.
Exclusion Criteria:
- History: of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- History of any clinically significant sensitivity or allergy to any medication or food.
- History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study treatment.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Part 1: Group 1
Participants will receive either single ascending doses of ABBV-1451 until they reach Dose A or placebo.
|
Infusie
Injection
Infusion
Injection
|
|
Experimenteel: Part 1: Group 2
Participants will receive either single ascending doses of ABBV-1451 until they reach Dose B or placebo.
|
Infusie
Injection
Infusion
Injection
|
|
Experimenteel: Part 1: Group 3
Participants will receive either single ascending doses of ABBV-1451 until they reach Dose C or placebo.
|
Infusie
Injection
Infusion
Injection
|
|
Experimenteel: Part 1: Group 4
Participants will receive either single ascending doses of ABBV-1451 until they reach Dose A or placebo.
|
Infusie
Injection
Infusion
Injection
|
|
Experimenteel: Part 1: Group 5
Participants will receive either single ascending doses of ABBV-1451 until they reach Dose C or placebo.
|
Infusie
Injection
Infusion
Injection
|
|
Experimenteel: Part 1: Group 6
Participants will receive either single ascending doses of ABBV-1451 until they reach Dose TBD or placebo.
|
Infusie
Injection
Infusion
Injection
|
|
Experimenteel: Part 2: Group 7
Japanese participants will receive a single dose of ABBV-1451 Dose C or placebo.
|
Infusie
Injection
Infusion
Injection
|
|
Experimenteel: Part 2: Group 8
Han Chinese participants will receive a single dose of ABBV-1451 Dose C or placebo.
|
Infusie
Injection
Infusion
Injection
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of Participants with Adverse Events (AEs)
Tijdsspanne: Up to Approximately Day 211
|
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
The investigator assesses the relationship of each event to the use of study.
|
Up to Approximately Day 211
|
|
Maximum Observed Plasma Concentration (Cmax) of ABBV-1451
Tijdsspanne: Up to Approximately Day 211
|
Cmax of ABBV-1451.
|
Up to Approximately Day 211
|
|
Time to Cmax (Tmax) of ABBV-1451
Tijdsspanne: Up to Approximately Day 211
|
Tmax of ABBV-1451.
|
Up to Approximately Day 211
|
|
Terminal Phase Elimination Rate Constant (β) of ABBV-1451
Tijdsspanne: Up to Approximately Day 211
|
β of ABBV-1451.
|
Up to Approximately Day 211
|
|
Terminal Phase Elimination Half-Life (t1/2) of ABBV-1451
Tijdsspanne: Up to Approximately Day 211
|
t1/2 of ABBV-1451.
|
Up to Approximately Day 211
|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-1451
Tijdsspanne: Up to Approximately Day 211
|
AUCt of ABBV-1451.
|
Up to Approximately Day 211
|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-1451
Tijdsspanne: Up to Approximately Day 211
|
AUCinf of ABBV-1451.
|
Up to Approximately Day 211
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: ABBVIE INC., AbbVie
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- M26-116
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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