A Study to Assess the Safety and Pharmacokinetics of Single Ascending Subcutaneous and Intravenou… (NCT05388903) | Clinical Trial Compass
CompletedPhase 1
A Study to Assess the Safety and Pharmacokinetics of Single Ascending Subcutaneous and Intravenous Doses of DS-2325a in Healthy Subjects
United States64 participantsStarted 2022-06-20
Plain-language 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 kallikrein 5, is expected to treat NS by replacing a defective gene.
Who can participate
Age range18 Years – 45 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Scre…
What they're measuring
1
Number of Participants with Any Treatment-emergent Adverse Events Following Administration of DS-2325a
Timeframe: Screening (Day -28 to -3) pre-dose up to Day 57 post-dose