Systemic Lupus ErythematosusPhase 1NCT05203692
A Study of a Single Ascending Dose Study of DS-7011a in Healthy Subjects
A Phase 1 study testing DS-7011a in people with Systemic Lupus Erythematosus, run by Daiichi Sankyo at 2 sites in United States.
Trial summary
This will be the first-in-human study designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of DS-7011a in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- DS-7011a
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Feb 2022to 22 Mar 2023
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female participants 18 to 45 years of age (inclusive), with a body mass index (BMI) of 18 kg/m^2 to 30 kg/m^2 (inclusive) at Screening.
- Participants fully vaccinated against COVID-19 per current CDC guidelines or recovered from prior SARS-CoV-2 infection.
- All women must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1.
- Women of childbearing potential must agree to use 2 different means of nonhormonal contraceptive methods.
- Women of non-childbearing potential must be either:
- Surgically sterile (ie, bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 months prior to dosing) or
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- Naturally postmenopausal for at least 24 consecutive months prior to dosing, spontaneous cessation of menses, with a follicle-stimulating hormone (FSH) level at Screening of ≥40 mIU/mL.
- Men must be surgically sterile (vasectomy 3 months before the dose of study drug) or agree to use approved contraception in addition to having their female partner (if of childbearing potential) use another acceptable form of contraception at any time during the study and for a period of 90 days after the dose of the study drug.
- Males may not donate sperm during the study for a period of 90 days
- Participants must be in overall good health, with no history of immunological and other chronic disorders, even if in remission and not requiring treatment.
- Confirmed Japanese ethnicity (Stage 3 only)
Who cannot join
- History or current chronic lung disease including asthma, COPD, or heavy smoking of >10 pack years
- Previous or current treatment with systemic corticosteroids or any immunosuppressive agents
- Participants who have received a transfusion or any blood products within the last year prior to dosing
- Participants who have made a blood donation or have had a loss of blood ≥500 mL within 56 days prior to the dose of study drug
- Participants who consume more than 28 units of alcohol per week (1 unit of alcohol equals 1/2 pint of beer, 4 ounces of wine, or 1 ounce of spirits) or those participants who have a significant history of alcoholism or drug/chemical abuse within the last 2 years
- Participants with positive results on tests for drugs of abuse, cotinine, or alcohol at Screening and/or Day -1
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Apex Clinical Research (Collaborative Neuroscience Research)
Long Beach, California, 90806
Worldwide Clinical Trials
San Antonio, Texas, 78217
About this study
Official title: A Phase 1, Subjects- and Investigator-Blinded, Sponsor-Unblinded, Placebo-Controlled, Randomized, Sequential Cohort Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous and Subcutaneous Doses of DS-7011a in Healthy Subjects
This will be the first-in-human study designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of DS-7011a in healthy participants.
Read the detailed description
This study will assess the safety, PK, and PD properties of single ascending intravenous (IV) and subcutaneous (SC) doses of DS-7011a in healthy participants.
This study will be conducted in 3 stages:
- Stage 1 - single ascending IV dose cohorts of DS-7011a (ie, up to 6 dose levels will be assessed starting at 0.1 mg/kg);
- Stage 2 - single ascending SC cohorts of DS-7011a (ie, up to 3 dose levels centered around the estimated therapeutic dose confirmed in Stage 1 will be assessed); and
- Stage 3 - a single IV cohort of DS-7011a in healthy participants of Japanese ethnicity (ie, 1 dose level at the estimated therapeutic dose as confirmed in Stage 1 will be assessed).
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- DS-7011a, Placebo
- Keywords
- Systemic Lupus Erythematosus, DS-7011a
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS-7011aDrug
Intravenous or subcutaneous administration, single dose
PlaceboDrug
Intravenous or subcutaneous administration, single dose
| Study group | Role | What they receive |
|---|---|---|
| DS-7011a | Experimental | Stage 1: Healthy participants who will be randomized to receive a single intravenous (IV) ascending dose of DS-7011a (starting dose 0.1 mg/kg).
Stage 2: Healthy participants who will be randomized to receive a single subcutaneous (SC) ascending dose of DS-7011a (starting dose will be centered around estimated therapeutic dose confirmed in Stage 1).
Stage 3: Healthy Japanese participants who will be randomized to receive an IV dose of DS-7011a (based on estimated therapeutic dose confirmed in Stage 1). Receives: Drug: DS-7011a |
| Placebo | Placebo comparator | Healthy participants who will be randomized to receive a single dose of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-emergent Adverse Events Following Administration with DS-7011a in Healthy Participants
Treatment-emergent adverse events (TEAEs) are defined as new adverse events (AEs) that occur after the dose of study drug or as AEs that were present prior to the dose of study drug but which worsened in severity after the start of study drug.
Measured: Screening (Day -28 to Day -7) up to Day 57 post-dose
Secondary outcomes (6)
Pharmacokinetic Parameter Area Under the Concentration Curve Following Administration of DS-7011a in Healthy Participants
Area under the plasma concentration-time curve up to time t (AUCt), area under the plasma concentration-time curve up to infinity (AUCinf), and the percentage of AUCinf based on extrapolation (AUCextrap) will be calculated using noncompartmental methods.
Measured: Stage 1 and 3: Pre-dose, end of infusion (EOI), and 1, 3, 6, 12, 24, 48, and 96 hours post-EOI, Days 8, 11, 15, 22, 29, 36, and 57; Stage 2: Pre-dose, and 1, 3, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose, Days 9-12, 15, 22, 29, 36, and 57
Pharmacokinetic Parameter Maximum Concentration Following Administration of DS-7011a in Healthy Participants
Maximum concentration (Cmax) will be calculated using noncompartmental methods.
Measured: Stage 1 and 3: Pre-dose, end of infusion (EOI), and 1, 3, 6, 12, 24, 48, and 96 hours post-EOI, Days 8, 11, 15, 22, 29, 36, and 57; Stage 2: Pre-dose, and 1, 3, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose, Days 9-12, 15, 22, 29, 36, and 57
Pharmacokinetic Parameter Time to Reach Maximum Plasma Concentration Following Administration of DS-7011a in Healthy Participants
Time to reach maximum plasma concentration (Tmax) will be calculated using noncompartmental methods.
Measured: Stage 1 and 3: Pre-dose, end of infusion (EOI), and 1, 3, 6, 12, 24, 48, and 96 hours post-EOI, Days 8, 11, 15, 22, 29, 36, and 57; Stage 2: Pre-dose, and 1, 3, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose, Days 9-12, 15, 22, 29, 36, and 57
Pharmacokinetic Parameter Terminal Half-life Following Administration of DS-7011a in Healthy Participants
Terminal half-life (t1/2) will be calculated using noncompartmental methods.
Measured: Stage 1 and 3: Pre-dose, end of infusion (EOI), and 1, 3, 6, 12, 24, 48, and 96 hours post-EOI, Days 8, 11, 15, 22, 29, 36, and 57; Stage 2: Pre-dose, and 1, 3, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose, Days 9-12, 15, 22, 29, 36, and 57
Mean Interleukin (IL)-6 Levels Following Administration of DS-7011a in Healthy Participants
Mean IL-6 levels in whole blood stimulations will be assessed using ligand-activated toll-like receptor (TLR7) which stimulates IL-6 production.
Measured: Stage 1 and 3: Pre-dose, end of infusion (EOI), and 1, 3, 6, 12, 24, 48, and 96 hours post-EOI, Days 8, 11, 15, 22, 29, 36, and 57; Stage 2: Pre-dose, and 1, 3, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose, Days 9-12, 15, 22, 29, 36, and 57
Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Proportion of Participants Who Have Treatment-emergent ADA
Measured: Pre-dose (Day 1) up to Day 57 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start2 Feb 2022
- Primary completion25 Jan 2023
- Study completion22 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203692
- Sponsor's protocol ID
- DS7011-A-U101
- Status last verified
- Apr 2023
- First submitted
- 20 Jan 2022
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Subjects- and Investigator-Blinded, Sponsor-Unblinded, Placebo-Controlled, Randomized, Sequential Cohort Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous and Subcutaneous Doses of DS-7011a in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05203692
- Acronym / sponsor ID
- DS7011-A-U101
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, DS-7011a
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 24 Jan 2022 (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.
This will be the first-in-human study designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of DS-7011a in healthy participants.
Detailed description
This study will assess the safety, PK, and PD properties of single ascending intravenous (IV) and subcutaneous (SC) doses of DS-7011a in healthy participants.
This study will be conducted in 3 stages:
- Stage 1 - single ascending IV dose cohorts of DS-7011a (ie, up to 6 dose levels will be assessed starting at 0.1 mg/kg);
- Stage 2 - single ascending SC cohorts of DS-7011a (ie, up to 3 dose levels centered around the estimated therapeutic dose confirmed in Stage 1 will be assessed); and
- Stage 3 - a single IV cohort of DS-7011a in healthy participants of Japanese ethnicity (ie, 1 dose level at the estimated therapeutic dose as confirmed in Stage 1 will be assessed).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DS-7011a | Experimental | Drug: DS-7011aStage 1: Healthy participants who will be randomized to receive a single intravenous (IV) ascending dose of DS-7011a (starting dose 0.1 mg/kg). Stage 2: Healthy participants who will be randomized to receive a single subcutaneous (SC) ascending dose of DS-7011a (starting dose will be centered around estimated therapeutic dose confirmed in Stage 1). Stage 3: Healthy Japanese participants who will be randomized to receive an IV dose of DS-7011a (based on estimated therapeutic dose confirmed in Stage 1). |
| Placebo | Placebo comparator | Drug: PlaceboHealthy participants who will be randomized to receive a single dose of placebo. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male and female participants 18 to 45 years of age (inclusive), with a body mass index (BMI) of 18 kg/m^2 to 30 kg/m^2 (inclusive) at Screening.
- Participants fully vaccinated against COVID-19 per current CDC guidelines or recovered from prior SARS-CoV-2 infection.
- All women must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1.
- Women of childbearing potential must agree to use 2 different means of nonhormonal contraceptive methods.
- Women of non-childbearing potential must be either:
Key exclusion criteria (6 listed)
- History or current chronic lung disease including asthma, COPD, or heavy smoking of >10 pack years
- Previous or current treatment with systemic corticosteroids or any immunosuppressive agents
- Participants who have received a transfusion or any blood products within the last year prior to dosing
- Participants who have made a blood donation or have had a loss of blood ≥500 mL within 56 days prior to the dose of study drug
- Participants who consume more than 28 units of alcohol per week (1 unit of alcohol equals 1/2 pint of beer, 4 ounces of wine, or 1 ounce of spirits) or those participants who have a significant history of alcoholism or drug/chemical abuse within the last 2 years
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 |
|---|---|---|
| DS-7011aIntravenous or subcutaneous administration, single dose | Drug | DS-7011a |
| PlaceboIntravenous or subcutaneous administration, single dose | Drug | Placebo |
Primary outcome
Number of Participants with Treatment-emergent Adverse Events Following Administration with DS-7011a in Healthy Participants
Time frame: Screening (Day -28 to Day -7) up to Day 57 post-dose
Treatment-emergent adverse events (TEAEs) are defined as new adverse events (AEs) that occur after the dose of study drug or as AEs that were present prior to the dose of study drug but which worsened in severity after the start of study drug.
6 secondary outcomes
Pharmacokinetic Parameter Area Under the Concentration Curve Following Administration of DS-7011a in Healthy Participants
Time frame: Stage 1 and 3: Pre-dose, end of infusion (EOI), and 1, 3, 6, 12, 24, 48, and 96 hours post-EOI, Days 8, 11, 15, 22, 29, 36, and 57; Stage 2: Pre-dose, and 1, 3, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose, Days 9-12, 15, 22, 29, 36, and 57
Pharmacokinetic Parameter Maximum Concentration Following Administration of DS-7011a in Healthy Participants
Time frame: Stage 1 and 3: Pre-dose, end of infusion (EOI), and 1, 3, 6, 12, 24, 48, and 96 hours post-EOI, Days 8, 11, 15, 22, 29, 36, and 57; Stage 2: Pre-dose, and 1, 3, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose, Days 9-12, 15, 22, 29, 36, and 57
Pharmacokinetic Parameter Time to Reach Maximum Plasma Concentration Following Administration of DS-7011a in Healthy Participants
Time frame: Stage 1 and 3: Pre-dose, end of infusion (EOI), and 1, 3, 6, 12, 24, 48, and 96 hours post-EOI, Days 8, 11, 15, 22, 29, 36, and 57; Stage 2: Pre-dose, and 1, 3, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose, Days 9-12, 15, 22, 29, 36, and 57
Pharmacokinetic Parameter Terminal Half-life Following Administration of DS-7011a in Healthy Participants
Time frame: Stage 1 and 3: Pre-dose, end of infusion (EOI), and 1, 3, 6, 12, 24, 48, and 96 hours post-EOI, Days 8, 11, 15, 22, 29, 36, and 57; Stage 2: Pre-dose, and 1, 3, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose, Days 9-12, 15, 22, 29, 36, and 57
Mean Interleukin (IL)-6 Levels Following Administration of DS-7011a in Healthy Participants
Time frame: Stage 1 and 3: Pre-dose, end of infusion (EOI), and 1, 3, 6, 12, 24, 48, and 96 hours post-EOI, Days 8, 11, 15, 22, 29, 36, and 57; Stage 2: Pre-dose, and 1, 3, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose, Days 9-12, 15, 22, 29, 36, and 57
Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Proportion of Participants Who Have Treatment-emergent ADA
Time frame: Pre-dose (Day 1) up to Day 57 post-dose
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 11 Apr 2023.
- 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.
Global Clinical Leader study director
Daiichi Sankyo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DS-7011a in people with Systemic Lupus Erythematosus, run by Daiichi Sankyo at 2 sites 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 11 inclusion and 6 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 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Treatment-emergent Adverse Events Following Administration with DS-7011a in Healthy Participants (time frame: Screening (Day -28 to Day -7) up to Day 57 post-dose). 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 11 Apr 2023.