HealthyPhase 1NCT03692949
A Study of LY3451838 in Healthy Participants
A Phase 1 study testing LY3451838 in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
Trial summary
The study has two parts. In Part A, single increasing doses of LY3451838 will be administered intravenously (into a vein). In Part B, a single dose of LY3451838 will be administered subcutaneously (just under the skin). Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3451838
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteSingapore
- Study dates
- 11 Dec 2018to 26 Feb 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male participants must adhere to contraception restrictions
- Female participants must be of non-childbearing potential due to:
- Menopause: spontaneous amenorrhea for at least 12 months not induced by a medical condition such as anorexia nervosa and not taking medications that induced the amenorrhea (e.g., oral contraceptives, hormones, gonadotropin releasing hormone, anti-estrogens, selective estrogen receptor modulators, or chemotherapy)
- Surgical sterilization
- Have a body mass index of 18 to 35 kilograms per square meter (kg/m²)
- Have clinical laboratory test results within normal reference range or with acceptable deviations
- Have an estimated glomerular filtration rate greater than or equal to (≥) 60 milliliters per minute per 1.73 meters squared (mL/minute/1.73 m²) of body surface area
- Have venous access sufficient to allow for blood sampling
Who cannot join
- Are currently enrolled in or discontinued from a clinical trial within the last 30 days, or have previously completed or withdrawn from this study
- Have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, renal, endocrine, psychiatric or neurological disease, or any clinically significant laboratory abnormality
- Have history of or presence of uncontrolled asthma, significant atopy, or significant rheumatological or autoimmune diseases
- Have had lymphoma, leukemia, or any malignancy within the past 5 years, or breast cancer within the past 10 years (with some exceptions)
- Have used, or intend to use some prescription or over the counter medications, including herbal medications within 14 days prior to dosing
- Have an abnormality in the 12-lead electrocardiogram (ECG) or Fridericia's corrected QT (QTcF)
Show all 16Show fewer
- Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies, hepatitis C and/or positive hepatitis C antibody, or hepatitis B and/or positive hepatitis B surface antigen
- Have donated blood of more than 450 milliliters (mL) within the last 3 months
- Are unwilling to stop alcohol consumption while resident in the Clinical Research Unit (CRU)
- Have an average weekly alcohol intake that exceeds 21 units per week for males and 14 units per week for females (1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
- Current smoker of more than 10 cigarettes or equivalent per day and unable to stop smoking while in the CRU
- Have an abnormal blood pressure
- Have clinically significant proteinuria or hematuria
- Positive findings for known drugs of abuse
- Have received treatment with biologic agents within 3 months or 5 half-lives (whichever is longer)
- Have clinically significant allergies, or intolerance to corticosteroids, or severe post treatment hypersensitivity reactions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Safety, Tolerability, and Pharmacokinetics Study of LY3451838 in Healthy Subjects
The study has two parts. In Part A, single increasing doses of LY3451838 will be administered intravenously (into a vein). In Part B, a single dose of LY3451838 will be administered subcutaneously (just under the skin).
- Conditions
- Healthy
- Being tested
- LY3451838, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3451838Drug
Administered IV Part A
LY3451838Drug
Administered IV Part A
LY3451838Drug
Administered IV Part A
LY3451838Drug
Administered IV Part A
LY3451838Drug
Administered IV Part A
LY3451838Drug
Administered IV Part A
LY3451838Drug
Administered SC Part B
PlaceboDrug
Administered IV in Part A and SC in Part B
| Study group | Role | What they receive |
|---|---|---|
| 25 milligram (mg) LY3451838 Part A | Experimental | 25 mg LY3451838 single dose administered intravenously (IV) Receives: Drug: LY3451838 |
| 75 mg LY3451838 Part A | Experimental | 75 mg LY3451838 single dose administered IV. Receives: Drug: LY3451838 |
| 250 mg LY3451838 Part A | Experimental | 250 mg LY3451838 single dose administered IV. Receives: Drug: LY3451838 |
| 500 mg LY3451838 Part A | Experimental | 500 mg LY3451838 single dose administered IV. Receives: Drug: LY3451838 |
| 1000 mg LY3451838 Part A | Experimental | 1000 mg LY3451838 single dose administered IV. Receives: Drug: LY3451838 |
| 1500 mg LY3451838 Part A | Experimental | 1500 mg LY3451838 single dose administered IV. Receives: Drug: LY3451838 |
| 250 mg LY3451838 Part B | Experimental | 250 mg LY3451838 single dose administered subcutaneously (SC). Receives: Drug: LY3451838 |
| Placebo | Placebo comparator | Placebo matching single dose administered IV in Part A or administered SC in Part B. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Any Treatment Emergent Adverse Event
A summary of other non-serious Adverse Events (AE's), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.
Measured: Baseline through 20 Weeks
Number of Participants With One or More Serious Adverse Events
A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Measured: Baseline through 20 Weeks
Secondary outcomes (2)
Pharmacokinetics (PK): Area Under the Serum Concentration-Time Curve From 0 to Infinity (AUC 0 -∞) of LY3451838
PK: AUC of LY3451838
Measured: Part A: Predose, End of Infusion, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dose; Part B: Predose, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dose
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY3451838
PK: Cmax of LY3451838
Measured: Part A: Predose, End of Infusion, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dose; Part B: Predose, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start11 Dec 2018
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692949
- Sponsor's protocol ID
- 17123
- Other IDs
- J1H-MC-LAJA
- Status last verified
- 1 Sep 2025
- First submitted
- 1 Oct 2018
- Last updated
- 11 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Johnson MP, Krikke-Workel J, Patel CN, Morin SM, Turner PK, Clark KA, Donley D, Jin Y, Johnson KW, Vincent M, Stille JR, Broad LM, Patel A. Preclinical and clinical evaluation of LY3451838, a PACAP-neutralizing monoclonal antibody, in randomized, double-blind, placebo-controlled phase 1 and phase 2 studies involving healthy adults and adults with treatment-resistant migraine. Cephalalgia. 2025 Aug;45(8):3331024251368757. doi: 10.1177/03331024251368757. Epub 2025 Aug 21.
PubMed 40836866
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety, Tolerability, and Pharmacokinetics Study of LY3451838 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03692949
- Acronym / sponsor ID
- 17123
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2018 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 2 Oct 2018 (actual)
- Results
- Posted 11 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study has two parts. In Part A, single increasing doses of LY3451838 will be administered intravenously (into a vein). In Part B, a single dose of LY3451838 will be administered subcutaneously (just under the skin).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 25 milligram (mg) LY3451838 Part A | Experimental | Drug: LY345183825 mg LY3451838 single dose administered intravenously (IV) |
| 75 mg LY3451838 Part A | Experimental | Drug: LY345183875 mg LY3451838 single dose administered IV. |
| 250 mg LY3451838 Part A | Experimental | Drug: LY3451838250 mg LY3451838 single dose administered IV. |
| 500 mg LY3451838 Part A | Experimental | Drug: LY3451838500 mg LY3451838 single dose administered IV. |
| 1000 mg LY3451838 Part A | Experimental | Drug: LY34518381000 mg LY3451838 single dose administered IV. |
| 1500 mg LY3451838 Part A | Experimental | Drug: LY34518381500 mg LY3451838 single dose administered IV. |
| 250 mg LY3451838 Part B | Experimental | Drug: LY3451838250 mg LY3451838 single dose administered subcutaneously (SC). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo matching single dose administered IV in Part A or administered SC in Part B. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male participants must adhere to contraception restrictions
- Female participants must be of non-childbearing potential due to:
- Have a body mass index of 18 to 35 kilograms per square meter (kg/m²)
- Have clinical laboratory test results within normal reference range or with acceptable deviations
- Have an estimated glomerular filtration rate greater than or equal to (≥) 60 milliliters per minute per 1.73 meters squared (mL/minute/1.73 m²) of body surface area
Key exclusion criteria (16 listed)
- Are currently enrolled in or discontinued from a clinical trial within the last 30 days, or have previously completed or withdrawn from this study
- Have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, renal, endocrine, psychiatric or neurological disease, or any clinically significant laboratory abnormality
- Have history of or presence of uncontrolled asthma, significant atopy, or significant rheumatological or autoimmune diseases
- Have had lymphoma, leukemia, or any malignancy within the past 5 years, or breast cancer within the past 10 years (with some exceptions)
- Have used, or intend to use some prescription or over the counter medications, including herbal medications within 14 days prior to dosing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3451838Administered IV Part A | Drug | 25 milligram (mg) LY3451838 Part A |
| LY3451838Administered IV Part A | Drug | 75 mg LY3451838 Part A |
| LY3451838Administered IV Part A | Drug | 250 mg LY3451838 Part A |
| LY3451838Administered IV Part A | Drug | 500 mg LY3451838 Part A |
| LY3451838Administered IV Part A | Drug | 1000 mg LY3451838 Part A |
| LY3451838Administered IV Part A | Drug | 1500 mg LY3451838 Part A |
| LY3451838Administered SC Part B | Drug | 250 mg LY3451838 Part B |
| PlaceboAdministered IV in Part A and SC in Part B | Drug | Placebo |
Primary outcome
Number of Participants With Any Treatment Emergent Adverse Event
Time frame: Baseline through 20 Weeks
A summary of other non-serious Adverse Events (AE's), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.
Number of Participants With One or More Serious Adverse Events
Time frame: Baseline through 20 Weeks
A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
2 secondary outcomes
Pharmacokinetics (PK): Area Under the Serum Concentration-Time Curve From 0 to Infinity (AUC 0 -∞) of LY3451838
Time frame: Part A: Predose, End of Infusion, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dose; Part B: Predose, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dose
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY3451838
Time frame: Part A: Predose, End of Infusion, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dose; Part B: Predose, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40836866Johnson MP, Krikke-Workel J, Patel CN, Morin SM, Turner PK, Clark KA, Donley D, Jin Y, Johnson KW, Vincent M, Stille JR, Broad LM, Patel A. Preclinical and clinical evaluation of LY3451838, a PACAP-neutralizing monoclonal antibody, in randomized, double-blind, placebo-controlled phase 1 and phase 2 studies involving healthy adults and adults with treatment-resistant migraine. Cephalalgia. 2025 Aug;45(8):3331024251368757. doi: 10.1177/03331024251368757. Epub 2025 Aug 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3451838 in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Any Treatment Emergent Adverse Event (time frame: Baseline through 20 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03692949, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.