A Study of a Single Ascending Dose Study of DS-7011a in Healthy Subjects

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 45 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.
  • - 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)

    Exclusion Criteria:

    - 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Daiichi Sankyo, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Global Clinical Leader
Principal Investigator Affiliation Daiichi Sankyo, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Systemic Lupus Erythematosus
Additional Details

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).

Arms & Interventions


Experimental: DS-7011a

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).

Placebo Comparator: Placebo

Healthy participants who will be randomized to receive a single dose of placebo.


Drug: - DS-7011a

Intravenous or subcutaneous administration, single dose

Drug: - Placebo

Intravenous or subcutaneous administration, single dose

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Long Beach, California


Not yet recruiting


Apex Clinical Research (Collaborative Neuroscience Research)

Long Beach, California, 90806

Site Contact

Principal Investigator

[email protected]


Worldwide Clinical Trials, San Antonio, Texas




Worldwide Clinical Trials

San Antonio, Texas, 78217

Site Contact

Principal Investigator

[email protected]