Status:
COMPLETED
A Study of a Single Ascending Dose Study of DS-7011a in Healthy Subjects
Lead Sponsor:
Daiichi Sankyo
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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.
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05203692
Start Date
February 2 2022
End Date
March 22 2023
Last Update
April 11 2023
Active Locations (2)
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1
Apex Clinical Research (Collaborative Neuroscience Research)
Long Beach, California, United States, 90806
2
Worldwide Clinical Trials
San Antonio, Texas, United States, 78217