A Study to Evaluate Safety, Tolerability of LY4100511 (DC-853) in Healthy Asian and Non-Asian Participants

DICE Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: LY4100511 (DC-853)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06311656

DCE853107 (Other Identifier)

J5C-MC-FOAA (Other Identifier)

18840

Details and patient eligibility

About

The main purpose of this study is to assess the safety and tolerability of LY4100511 (DC-853) after single and multiple dose administrations in healthy asian participants and non-Asian participants. Part A consists of 2 groups and Part B, C, and D include optional groups.

Full description

Part B and C added per protocol amendment (May 2024) Added Part B to explore higher dose levels and Part C to explore effects of food. Part D added per protocol amendment (June 2024) to explore higher multiple doses.

Enrollment: 69 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and female participants who are overtly healthy as determined by medical history, vital signs, and physical examination.
• Participants of Japanese, Chinese, and Non-Asian ethnicities
• Have a body mass index within the range of 18.0 to 32 kilograms per square meter (kg/m²). For healthy Japanese participants, have a body mass index of 18.0 to 28.0 kg/m²
• Have venous access sufficient to allow for blood sampling
• Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion criteria

• Have a current or recent acute, active infection
• Had any surgical procedure within 12 weeks prior to study
• Are immunocompromised
• Have presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric disorders or abnormal laboratory values
• Are currently enrolled in a clinical study involving any experimental antibody or biologic therapy within the previous 6 months, or any other experimental therapy within 30 days before the first dose of the study intervention or during the study

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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69 participants in 5 patient groups, including a placebo group

LY4100511 (DC-853) Part A Fasted

Experimental group

Description:

Single and multiple doses of LY4100511 (DC-853) administered orally.

Treatment:

Drug: LY4100511 (DC-853)

Drug: LY4100511 (DC-853)

Drug: LY4100511 (DC-853)

Drug: LY4100511 (DC-853)

LY4100511 (DC-853) Part B

Experimental group

Description:

Single and multiple higher doses of LY4100511 (DC-853) administered orally.

Treatment:

Drug: LY4100511 (DC-853)

Drug: LY4100511 (DC-853)

Drug: LY4100511 (DC-853)

Drug: LY4100511 (DC-853)

LY4100511 (DC-853) Part C (Open Label)

Experimental group

Description:

Single dose of LY4100511 (DC-853) administered orally in fed and fasted states.

Treatment:

Drug: LY4100511 (DC-853)

Drug: LY4100511 (DC-853)

Drug: LY4100511 (DC-853)

Drug: LY4100511 (DC-853)

LY4100511 (DC-853) Part D

Experimental group

Description:

Multiple higher doses of LY4100511 (DC-853) administered orally.

Treatment:

Drug: LY4100511 (DC-853)

Drug: LY4100511 (DC-853)

Drug: LY4100511 (DC-853)

Drug: LY4100511 (DC-853)

Placebo

Placebo Comparator group

Description:

Placebo administered orally.

Treatment:

Drug: Placebo