Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-002888-21 | EudraCT Number | ||
| J5B-MC-FHAB | Other Identifier | Eli Lilly and Company | |
| 297326 | Other Identifier | NHS Health Research Authority | |
| 18850 | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: DC-806 | Experimental | Single ascending dose of DC-806 administered orally. |
|
| Part 1: Placebo | Placebo Comparator | Placebo administered orally. |
|
| Part 2: DC-806 | Experimental | Multiple ascending doses of DC-806 administered orally. |
|
| Part 2: Placebo | Placebo Comparator | Placebo administered orally |
|
| Part 3:DC-806 | Experimental | DC-806 administered orally |
|
| Part 3: Placebo | Placebo Comparator | Placebo administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC-806 | Drug | administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1, Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of DC-806. | PK: 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. |
Not provided
Inclusion Criteria:
Healthy Subjects (Parts 1 and 2)
Participants with Psoriasis (Part 3)
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:
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:
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.
Female subjects with a positive serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) at screening or within 24 h prior to the first administration of IMP.
Positive serum hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCV Ab) or human immunodeficiency virus (HIV) 1 and/or 2 antibodies at screening.
Part 2 Only: Presence of active suicidal ideation or positive suicide behaviour using the "Baseline/Screening" version of the Columbia Suicide Severity Rating Scale (C-SSRS) and with either of the following criteria:
Participants with Psoriasis (Part 3)
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Medicines Evaluation Unit (MEU) Ltd. | Manchester | M23 9QZ | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | administered orally. |
|
PK: AUC of DC-806.
| Pre-dose up-to 48 hours post-dose |
| Part 1, PK: Time to reach maximum observed (Tmax) of DC-806 | PK: 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 | PK: Half-life (T1/2) DC-806 | Pre-dose up-to 48 hours post-dose |
| Part 2, PK: Maximum Observed Concentration (Cmax) of DC-806 | PK: Cmax of DC-806 | Pre-dose up-to 48 hours post-dose |
| Part 2, PK: Area Under the Concentration Versus Time Curve (AUC) of DC-806 | PK: AUC of DC-806 | Pre-dose up-to 48 hours post-dose |
| Part 2, PK: Time to reach maximum observed (Tmax) of DC-806 | PK: Tmax of DC-806 | Pre-dose up-to 48 hours post-dose |
| Part 2, PK: First-order elimination half-life (T1/2) of DC-806 | PK: Half-life (T1/2) DC-806 | Pre-dose up-to 48 hours post-dose |
| Part 3, PK: Maximum Observed Concentration (Cmax) of DC-806 | PK: Cmax of DC-806 | Pre-dose up-to 48 hours post-dose |
| Part 3, PK: Ctrough of DC-806 | pre-dose of DC-806 | Pre-dose up-to 48 hours post-dose |