HealthyPhase 1NCT04133116
A Study of LY3471851 in Healthy Participants
A Phase 1 study testing LY3471851 in people with Healthy, run by Nektar Therapeutics at 1 site in United States.
Trial summary
The main purpose of this study is to explore the safety and tolerability of LY3471851 in healthy Japanese and Caucasian participants. The study will also estimate how much LY3471851 gets into the blood stream and how long it takes the body to remove it. The study is expected to last about 7 weeks for each participant. Read more about this study
- Who is it for?
- Ages 20 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3471851
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2019to 6 Mar 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 20 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are healthy males or females, as determined by medical history and physical examination
- Are first generation Japanese or are Caucasian
- Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive, at the time of screening
Who cannot join
- Are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study
- Have an abnormal blood pressure and/or pulse rate as determined by the investigator
- Regularly use known drugs of abuse and/or show positive findings on drug screening
- Are immunocompromised per investigator judgment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3471851 in Japanese and Caucasian Healthy Subjects
The main purpose of this study is to explore the safety and tolerability of LY3471851 in healthy Japanese and Caucasian participants. The study will also estimate how much LY3471851 gets into the blood stream and how long it takes the body to remove it. The study is expected to last about 7 weeks for each participant.
- Conditions
- Healthy
- Being tested
- LY3471851, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3471851Drug
Also called NKTR-358
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| LY3471851 | Experimental | Participants received single doses of 450 microgram (μg), 900 μg or 1800 μg LY3471851 administered subcutaneously (SC). Receives: Drug: LY3471851 |
| Placebo | Placebo comparator | Placebo matching LY3471851 administered SC. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline through Study Completion (up to week 7)
Secondary outcomes (2)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3471851
PK: AUC of LY3471851
Measured: Predose on Day 1 through Day 50
PK: Maximum Concentration (Cmax) of LY3471851
PK: Cmax of LY3471851
Measured: Predose on Day 1 through Day 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start29 Oct 2019
- Primary completion6 Mar 2020
- Study completion6 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nektar Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Nektar Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133116
- Sponsor's protocol ID
- 17414
- Other IDs
- J1P-MC-KFAI
- Status last verified
- Nov 2023
- First submitted
- 18 Oct 2019
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3471851 in Japanese and Caucasian Healthy Subjects
- ClinicalTrials.gov ID
- NCT04133116
- Acronym / sponsor ID
- 17414
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Nektar TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- 29 Oct 2019 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 21 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to explore the safety and tolerability of LY3471851 in healthy Japanese and Caucasian participants. The study will also estimate how much LY3471851 gets into the blood stream and how long it takes the body to remove it. The study is expected to last about 7 weeks for each participant.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY3471851 | Experimental | Drug: LY3471851Participants received single doses of 450 microgram (μg), 900 μg or 1800 μg LY3471851 administered subcutaneously (SC). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo matching LY3471851 administered SC. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Are healthy males or females, as determined by medical history and physical examination
- Are first generation Japanese or are Caucasian
- Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive, at the time of screening
Key exclusion criteria (4 listed)
- Are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study
- Have an abnormal blood pressure and/or pulse rate as determined by the investigator
- Regularly use known drugs of abuse and/or show positive findings on drug screening
- Are immunocompromised per investigator judgment
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 |
|---|---|---|
| LY3471851Also: NKTR-358Administered SC | Drug | LY3471851 |
| PlaceboAdministered SC | Drug | Placebo |
Primary outcome
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline through Study Completion (up to week 7)
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
2 secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3471851
Time frame: Predose on Day 1 through Day 50
PK: Maximum Concentration (Cmax) of LY3471851
Time frame: Predose on Day 1 through Day 50
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Study Director study director
Nektar Therapeutics
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 LY3471851 in people with Healthy, run by Nektar Therapeutics at 1 site in United States.
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 3 inclusion and 4 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 18 Nov 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline through Study Completion (up to week 7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2023.