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A Study to Assess S011806 (DC-806 or LY4100504) in Healthy Adult Participants and Participants With Chronic Plaque Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study to Assess S011806 (DC-806 or LY4100504) in Healthy Adult Participants and Participants With Chronic Plaque Psoriasis

A Phase I, Randomized, Double-Blinded, Placebo-Controlled, 3-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending and Multiple Ascending Doses of S011806 in Healthy Participants and Multiple Doses of S011806 in Patients With Chronic Plaque Psoriasis

NCT06808815•DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The main purpose of this study is to learn more about the safety and side effects of DC-806 when given by mouth to healthy participants and participants with Chronic Plaque Psoriasis. The study will have three parts. Each participant will enroll in only one part. For each participant, Part 1 will last up to 14 weeks, Part 2 will last up to 12 weeks, Part 3 will last up to 11 weeks including screening and follow-up.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy Subjects (Parts 1 and 2)
•Men and women participants must be between 18-55 years inclusive, at the time of informed consent.
•Female participants must either be of non-childbearing potential or if of childbearing potential, must not be pregnant, breast feeding or lactating and use a highly effective birth control method during treatment and for 90 days following last administered dose. In addition, male partners of female subjects of childbearing potential must use highly effective contraception for 90 days following the last administered dose
•Male participants who are sexually active with a partner of childbearing potential must use, with their partner, a condom plus an approved method of highly effective contraception from the time of informed consent until 90 days after their last dose of IMP.
•Participants must agree not to donate semen or ova/oocytes during the study and for 90 days after the last dose of IMP.
•Participants must have a body mass index (BMI) ≥ 18 and ≤ 35 kg/m2.
•Participants must be in good health as determined by medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory assessments at the time of screening, as judged by the Investigator or designee.
•Participants with Psoriasis (Part 3)
•Men and women Participants must be between 18-65 years inclusive, at the time of informed consent.
•Participants must have a documented diagnosis of plaque psoriasis for ≥ 6 months prior to screening.
+6 more criteria

Exclusion Criteria

•Healthy Subjects (Parts 1 and 2)
•History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the subject's safety during the clinical study or expose the subject to undue risk as judged by the Investigator or designee.
•After 10 minutes supine rest at the time of screening or prior to dosing on Day 1, any vital signs values outside the following ranges:
•* Systolic blood pressure \<90 or \>150 mmHg, or
•* Diastolic blood pressure \<50 or \>95 mmHg, or
•* Pulse \<40 or \>90 bpm
•Any clinically significant abnormalities in resting ECG at the time of screening or pre-dose Day 1 including prolonged QTcF (\>450 ms for males; \>470 ms for females using the mean of triplicate ECG's) and cardiac arrhythmias, as judged by the Investigator or designee.
•Clinically significant abnormalities in renal function:
•• eGFR \<60 mL/min
•Clinically significant abnormalities in liver function:
+21 more criteria

Locations (1)

The Medicines Evaluation Unit (MEU) Ltd.

Manchester, United Kingdom

Key Dates

Start Date

September 22, 2021

Primary Completion Date

August 23, 2022

Completion Date

August 23, 2022

Last Updated

February 5, 2025

Enrollment

104

ACTUAL participants

Conditions

Plaque Psoriasis

Interventions

DC-806

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Assess S011806 (DC-806 or LY4100504) in Healthy Adult Participants and Participants With Chronic Plaque Psoriasis

Inclusion Criteria

Exclusion Criteria

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis