Trial Outcomes & Findings for A Study of LY3872386 in Healthy Participants and Participants With Atopic Dermatitis (NCT NCT06119529)
NCT ID: NCT06119529
Last Updated: 2025-10-03
Results Overview
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is located in the Reported Adverse Event module. Drug related TEAEs are any untoward medical occurrences that either occurs postdose or presents prior to dosing yet becomes more severe postdose, and in the opinion of the investigator is possibly related to study drug.
TERMINATED
PHASE1
18 participants
Baseline through Day 85
2025-10-03
Participant Flow
The study was designed to include three parts (A, B, and C). Results are reported only for Part A, as Parts B and C were not initiated and the study was terminated early due to emerging nonclinical data. In Part A, single-ascending dose (SAD), of the LY3872386 (SAD Cohorts 1 and 2 and the sentinel pair in SAD Cohort 3,) was administered to healthy participants on Day 1, followed by a 12-week follow-up period.
Participant milestones
| Measure |
Part A: Low Dose LY3872386
Participants received a single low dose of LY3872386 administered IV in healthy participants.
|
Part A: Mid-dose LY3872386
Participants received a single mid-dose of LY3872386 administered IV in healthy participants.
|
Part A: High Dose LY3872386
Participants received a single high dose of LY3872386 administered IV in healthy participants.
|
Part A: Placebo
Participants received placebo administered IV in healthy participants.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
1
|
5
|
|
Overall Study
Received at Least One Dose of Study Drug
|
6
|
6
|
1
|
5
|
|
Overall Study
COMPLETED
|
6
|
6
|
1
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of LY3872386 in Healthy Participants and Participants With Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Part A: Low Dose LY3872386
n=6 Participants
Participants received a single low dose of LY3872386 administered IV in healthy participants.
|
Part A: Mid-dose LY3872386
n=6 Participants
Participants received a single mid-dose of LY3872386 administered IV in healthy participants.
|
Part A: High Dose LY3872386
n=1 Participants
Participants received a single high dose of LY3872386 administered IV in healthy participants.
|
Part A: Placebo
n=5 Participants
Placebo administered IV in healthy participants.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline through Day 85Population: All randomized participants who received at least one dose of study drug.
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is located in the Reported Adverse Event module. Drug related TEAEs are any untoward medical occurrences that either occurs postdose or presents prior to dosing yet becomes more severe postdose, and in the opinion of the investigator is possibly related to study drug.
Outcome measures
| Measure |
Part A: Low Dose LY3872386
n=6 Participants
Participants received a single low dose of LY3872386 administered IV in healthy participants.
|
Part A: Mid-dose LY3872386
n=6 Participants
Participants received a single mid-dose of LY3872386 administered IV in healthy participants.
|
Part A: High Dose LY3872386
n=1 Participants
Participants received a single high dose of LY3872386 administered IV in healthy participants.
|
Part A: Placebo IV
n=5 Participants
Placebo administered IV in healthy participants.
|
|---|---|---|---|---|
|
Part A: Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs) and Other Non-serious Adverse Events (AEs) Considered by the Investigator to be Related to Study Drug Administration
TEAEs
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Part A: Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs) and Other Non-serious Adverse Events (AEs) Considered by the Investigator to be Related to Study Drug Administration
SAEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Part A: Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs) and Other Non-serious Adverse Events (AEs) Considered by the Investigator to be Related to Study Drug Administration
AEs
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline through Day 183Population: Zero participants were analyzed for this outcome. Data were not captured as study was terminated early, and no participant were enrolled into Part B.
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is located in the Reported Adverse Event module. Drug related TEAEs are any untoward medical occurrences that either occurs postdose or presents prior to dosing yet becomes more severe postdose, and in the opinion of the investigator is possibly related to study drug. Zero participants were analyzed in this outcome as study was terminated early.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline through Day 44Population: Zero participants were analyzed for this outcome. Data were not captured as study was terminated early, and no participant were enrolled into Part C.
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is located in the Reported Adverse Event module. Drug related TEAEs are any untoward medical occurrences that either occurs postdose or presents prior to dosing yet becomes more severe postdose, and in the opinion of the investigator is possibly related to study drug. Zero participants were analyzed in this outcome as study was terminated early.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1: predose, end of infusion, 3 hours, 6 hours, and 12 hours postdose, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose (Part A)Population: All enrolled participants who received at least one dose of LY3872386 and had evaluable PK data in Part A. Zero participants were analyzed for Part B. Data were not captured as study was terminated early, and no participant were enrolled into Part B.
Cmax of LY3872386 is reported.
Outcome measures
| Measure |
Part A: Low Dose LY3872386
n=6 Participants
Participants received a single low dose of LY3872386 administered IV in healthy participants.
|
Part A: Mid-dose LY3872386
n=6 Participants
Participants received a single mid-dose of LY3872386 administered IV in healthy participants.
|
Part A: High Dose LY3872386
n=1 Participants
Participants received a single high dose of LY3872386 administered IV in healthy participants.
|
Part A: Placebo IV
Placebo administered IV in healthy participants.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Part A and B: Maximum Observed Concentration (Cmax) of LY3872386
|
2.54 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 16.9
|
7.89 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 16.3
|
NA micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation NA
Geometric Mean and %CV not calculated for 1 participant. Individual Value = 23.09 µg/mL
|
—
|
SECONDARY outcome
Timeframe: Day 1: predose, end of infusion, 3 hours, 6 hours, and 12 hours postdose, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose (Part A)Population: All enrolled participants who received at least one dose of LY3872386 and had evaluable PK data in Part A. Zero participants were analyzed for Part B. Data were not captured as study was terminated early, and no participant were enrolled into Part B.
Area Under the Concentration Versus Time Curve from Time Zero to tlast (AUC\[0-tlast\]) and Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC\[0-inf\]) of LY3872386 is reported.
Outcome measures
| Measure |
Part A: Low Dose LY3872386
n=6 Participants
Participants received a single low dose of LY3872386 administered IV in healthy participants.
|
Part A: Mid-dose LY3872386
n=6 Participants
Participants received a single mid-dose of LY3872386 administered IV in healthy participants.
|
Part A: High Dose LY3872386
n=1 Participants
Participants received a single high dose of LY3872386 administered IV in healthy participants.
|
Part A: Placebo IV
Placebo administered IV in healthy participants.
|
|---|---|---|---|---|
|
PK: Part A and B: Area Under the Concentration Versus Time Curve (AUC) of LY3872386
AUC(0-tlast) of LY3872386
|
55.7 microgram*hour per milliliter(µg*hr/mL)
Geometric Coefficient of Variation 15.6
|
328 microgram*hour per milliliter(µg*hr/mL)
Geometric Coefficient of Variation 19.7
|
NA microgram*hour per milliliter(µg*hr/mL)
Geometric Coefficient of Variation NA
Geometric Mean and %CV not calculated for 1 participant. Individual Value = 1480 µg\*h/mL
|
—
|
|
PK: Part A and B: Area Under the Concentration Versus Time Curve (AUC) of LY3872386
AUC(0-∞) of LY3872386
|
65.8 microgram*hour per milliliter(µg*hr/mL)
Geometric Coefficient of Variation 18.6
|
337 microgram*hour per milliliter(µg*hr/mL)
Geometric Coefficient of Variation 20.3
|
NA microgram*hour per milliliter(µg*hr/mL)
Geometric Coefficient of Variation NA
Geometric Mean and %CV not calculated for 1 participant. Individual Value = 1560 µg\*h/mL
|
—
|
SECONDARY outcome
Timeframe: Predose up to 12 hours post dose on day 14 and day 30Population: Zero participants were analyzed for this outcome. Data were not captured as study was terminated early, and no participant were enrolled into Part C.
Zero participants were analyzed in this outcome as study was terminated early.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose up to 12 hours post dose on day 14 and day 30Population: Zero participants were analyzed for this outcome. Data were not captured as study was terminated early, and no participant were enrolled into Part C.
Zero participants were analyzed in this outcome as study was terminated early.
Outcome measures
Outcome data not reported
Adverse Events
Part A: Low Dose LY3872386
Part A: Mid-dose LY3872386
Part A: High Dose LY3872386
Part A: Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A: Low Dose LY3872386
n=6 participants at risk
Participants received a single low dose of LY3872386 administered IV in healthy participants.
|
Part A: Mid-dose LY3872386
n=6 participants at risk
Participants received a single mid-dose of LY3872386 administered IV in healthy participants.
|
Part A: High Dose LY3872386
n=1 participants at risk
Participants received a single high dose of LY3872386 administered IV in healthy participants.
|
Part A: Placebo
n=5 participants at risk
Participants received placebo administered IV in healthy participants.
|
|---|---|---|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/6 • Baseline up to Day 85
All randomized participants who received at least one dose of the study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to Day 85
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/1 • Baseline up to Day 85
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/5 • Baseline up to Day 85
All randomized participants who received at least one dose of the study drug.
|
|
Eye disorders
Keratitis
|
16.7%
1/6 • Number of events 2 • Baseline up to Day 85
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/6 • Baseline up to Day 85
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/1 • Baseline up to Day 85
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/5 • Baseline up to Day 85
All randomized participants who received at least one dose of the study drug.
|
|
General disorders
Injection site erythema
|
0.00%
0/6 • Baseline up to Day 85
All randomized participants who received at least one dose of the study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to Day 85
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/1 • Baseline up to Day 85
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/5 • Baseline up to Day 85
All randomized participants who received at least one dose of the study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Baseline up to Day 85
All randomized participants who received at least one dose of the study drug.
|
33.3%
2/6 • Number of events 2 • Baseline up to Day 85
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/1 • Baseline up to Day 85
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/5 • Baseline up to Day 85
All randomized participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • Baseline up to Day 85
All randomized participants who received at least one dose of the study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to Day 85
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/1 • Baseline up to Day 85
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/5 • Baseline up to Day 85
All randomized participants who received at least one dose of the study drug.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/6 • Baseline up to Day 85
All randomized participants who received at least one dose of the study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to Day 85
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/1 • Baseline up to Day 85
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/5 • Baseline up to Day 85
All randomized participants who received at least one dose of the study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60