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

NCT06808815 | Completed Phase 1 FDA Drug

• 5 other identifiers: DCE8061012021-002888-21J5B-MC-FHAB29732618850
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (3)

• Part 1: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug.

  A summary of AEs, TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module.

  Baseline Up To 7 Weeks

• Part 2: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug.

  A summary of AEs, TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module.

  Baseline Up To 7 Weeks

• Part 3: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug.

  A summary of AEs, TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module.

  Baseline Up To 11 Weeks

Secondary Outcomes (10)

• Part 1, Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of DC-806.

  Pre-dose up-to 48 hours post-dose

• Part 1, PK: Area Under the Concentration Versus Time Curve (AUC) of DC-806.

  Pre-dose up-to 48 hours post-dose

• Part 1, PK: Time to reach maximum observed (Tmax) of DC-806

  Pre-dose up-to 48 hours post-dose

• Part 1, PK: First-order elimination half-life (T1/2) of DC-806

  Pre-dose up-to 48 hours post-dose

• Part 2, PK: Maximum Observed Concentration (Cmax) of DC-806

  Pre-dose up-to 48 hours post-dose

Study Arms (6)

Part 1: DC-806

EXPERIMENTAL

Single ascending dose of DC-806 administered orally.

Drug: DC-806

Part 1: Placebo

PLACEBO COMPARATOR

Placebo administered orally.

Other: Placebo

Part 2: DC-806

EXPERIMENTAL

Multiple ascending doses of DC-806 administered orally.

Drug: DC-806

Part 2: Placebo

PLACEBO COMPARATOR

Placebo administered orally

Other: Placebo

Part 3:DC-806

EXPERIMENTAL

DC-806 administered orally

Drug: DC-806

Part 3: Placebo

PLACEBO COMPARATOR

Placebo administered orally

Other: Placebo

Interventions

DC-806 DRUG

administered orally.

Also known as: S011806, LY4100504

Part 1: DC-806; Part 2: DC-806; Part 3:DC-806

Placebo OTHER

administered orally.

Part 1: Placebo; Part 2: Placebo; Part 3: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Physicians Global Assessment (PGA) of 2/3 i.e. mild or moderate plaque psoriasis at baseline.
• Body Surface Area (BSA) ≥3% at baseline.
• A minimum of 2 psoriatic lesions of at least 2 cm x 2 cm at baseline, with at least 1 plaque in a site suitable for biopsy.
• 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.

You may not qualify if:

• 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:
• Bilirubin \>1.5 x ULN
• Aminotransferases \>1.5 x ULN
• ALP \>1.5 x ULN
• History of latent TB, active tuberculosis, or a positive QuantiFERON® TB Gold result at screening. Patients with an indeterminate QuantiFERON® TB Gold result at screening will be allowed one retest; if not negative on retesting, the subject will be excluded.
• Females who are pregnant, breast feeding or plan to be pregnant during the study period or 90 days after.

Sponsors & Collaborators

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

Study Sites (1)

The Medicines Evaluation Unit (MEU) Ltd.

Manchester, M23 9QZ, United Kingdom

Location

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 W Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 5, 2025
• Study Start: September 22, 2021
• Primary Completion: August 23, 2022
• Study Completion: August 23, 2022
• Last Updated: February 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)