Healthy VolunteersPhase 1NCT05305222

A Study in Healthy Japanese and Caucasian Subjects to Assess the Pharmacokinetics, Safety and Tolerability of Risankizumab

A Phase 1 study testing Risankizumab in people with Healthy Volunteers, run by AbbVie at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The main objective of this study is to assess the pharmacokinetics, safety, tolerability and immunogenicity following a single intravenous (IV) infusion of risankizumab in healthy Japanese and Caucasian participants. Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Risankizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 17 participants
Where: 1 siteUnited States
Study dates: 23 Oct 2017to 15 Jun 2018
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Must be first or second generation Japanese of full parentage residing outside of Japan for less than 10 years. First generation participants will have been born 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. All participants must maintain a typical Japanese lifestyle, including consuming a typical Japanese diet or participants must be Caucasian and not of Hispanic ethnicity.
Body Mass Index (BMI) is >= 18.5 and <= 29.9 kg/m2 (after rounding to the tenths decimal) at Screening. BMI is calculated as weight in kilograms (kg) divided by the square of height measured in meters (m).

Who cannot join

Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
Any findings in the medical examination that are deviating from normal and judged as clinically relevant by the investigator.
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
Any evidence of a concomitant disease judged as clinically relevant by the investigator.

Trial locations and contacts

1 site in 1 country.

United States1 site

Altasciences Clinical Los Angeles, Inc /ID# 164197
Cypress, California, 90630

Other trials in United States

About this study

Official title: A Study in Healthy Japanese and Caucasian Subjects to Assess the Pharmacokinetics, Safety and Tolerability After a Single Dose of Risankizumab

Conditions: Healthy Volunteers
Being tested: Risankizumab, Placebo
Keywords: Healthy Volunteers, Risankizumab, Skyrizi

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RisankizumabDrug
Also called SKYRIZI, ABBV-066
Intravenous (IV) Infusion
PlaceboDrug
Intravenous (IV) Infusion

Study groups in NCT05305222
Study group	Role	What they receive
Japanese Participants Receiving Risankizumab	Experimental	Participants will receive single dose of risankizumab. Receives: Drug: Risankizumab
Japanese Participants Receiving Placebo	Experimental	Participants will receive single dose of placebo. Receives: Drug: Placebo
Caucasian Participants Receiving Risankizumab	Experimental	Participants will receive single dose of risankizumab. Receives: Drug: Risankizumab
Caucasian Participants Receiving Placebo	Experimental	Participants will receive single dose of placebo. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Experiencing Adverse Events
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Measured: Up to approximately 137 days
Maximum Observed Plasma Concentration (Cmax) of Risankizumab
Maximum observed plasma concentration (Cmax) of Risankizumab.
Measured: Up to approximately 137 days
Time to Cmax (Cmax) of Risankizumab
Tmax of Risankizumab.
Measured: Up to approximately 137 days
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Last Measurable Concentration (AUCt) of Risankizumab
AUCt of Risankizumab.
Measured: Up to approximately 137 days
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCinf) of Risankizumab
AUCinf of Risankizumab.
Measured: Up to approximately 137 days
Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab
Apparent terminal phase elimination rate constant (β) of Risankizumab.
Measured: Up to approximately 137 days
Terminal Phase Elimination Half-life (t1/2) of Risankizumab
Terminal phase elimination half-life (t1/2) of Risankizumab.
Measured: Up to approximately 137 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Oct 201715 Jun 2018

First posted31 Mar 2022
Study start23 Oct 2017
Primary completion15 Jun 2018
Study completion15 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05305222
Sponsor's protocol ID: M16-533
Status last verified: Mar 2022
First submitted: 23 Mar 2022
Last updated: 31 Mar 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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