Status:
COMPLETED
A Study to Assess the Safety and Pharmacokinetics of Single Ascending Subcutaneous and Intravenous Doses of DS-2325a in Healthy Subjects
Lead Sponsor:
Daiichi Sankyo
Conditions:
Netherton Syndrome
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Netherton syndrome (NS) is a rare autosomal recessive disease and no systemic treatment or standard of care currently exists for patients with NS. DS-2325a, a specific and potent inhibitor of kallikre...
Detailed Description
This first-in-human study for DS-2325a will evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of DS-2325a in healthy participants. DS-2325a will be evaluated after both...
Eligibility Criteria
Inclusion
- Participants must give written informed consent to participation in the study prior to Screening
- Healthy men and women 18 to 45 years of age (inclusive), with a BMI of 18 kg/m2 to 30 kg/m\^2 (inclusive) at Screening
- All women must have a negative serum pregnancy test at Screening and all women of childbearing potential must have a negative urine pregnancy test on Day -1
- Women must not be lactating during the study treatment period and for 3 months after the last dose of study treatment
- Women of childbearing potential must practice effective contraception during the study treatment period and for 3 months after the last dose of study treatment. They 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 at least 3 months prior to dosing) or in menopausal state confirmed as follows: 1 year of spontaneous amenorrhea without an alternative medical cause and a serum FSH level ≥40 mIU/mL
- Men must agree to use contraception (condom with spermicide) during the study treatment period and for at least 3 months after the last dose of study treatment or be surgically sterile (vasectomy at least 3 months prior to dosing)
- Women should not donate eggs and men should not donate sperm during the study treatment period and for at least 3 months after the last dose of study treatment
- Participants must be in good health as determined by Screening medical history, physical examination, vital signs, ECGs, serum chemistry, hematology, virology, and urinalysis performed at Screening and on Day -1
Exclusion
- History or current chronic lung disease including asthma, chronic obstructive pulmonary disease (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 any blood donation or have had a loss of blood of ≥500 mL within 56 days prior to the dose of study drug
- Participants who consume more than 21 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 :
June 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2023
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT05388903
Start Date
June 20 2022
End Date
January 26 2023
Last Update
March 6 2023
Active Locations (1)
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1
Worldwide Clinical Trials
San Antonio, Texas, United States, 78217