A Study to Assess the Safety and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of DS-… (NCT05583669) | Clinical Trial Compass
CompletedPhase 1
A Study to Assess the Safety and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of DS-2325a in Healthy Subjects
United States24 participantsStarted 2022-11-08
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 – 50 Years
SexALL
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Inclusion Criteria:
* Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures.
* Must be willing and able to comply with all study requirements.
* Healthy males or non-pregnant, non-lactating healthy females.
* Aged 18 to 50 years of age (inclusive) at the time of signing informed consent.
* BMI of 18.0 kg/m\^2 to 30.0 kg/m\^2 (inclusive) as measured at Screening.
* Women of childbearing potential who are sexually active with a male partner must practice effective contraception during the study treatment period and for 90 days after last IMP administration. They must agree to use 2 different means of nonhormonal contraceptive methods.
* Women of non-childbearing potential must be either surgically sterile or in menopausal state confirmed as follows: 1 year of spontaneous amenorrhea without an alternative medical cause and a serum follicle stimulating hormone (FSH) level ≥40 mIU/mL.
* Male participants who are sexually active with a female partner of childbearing potential must use, with their partner, a condom plus an approved method of highly effective contraception from the time of informed consent until 90 days after last IMP administration.
* Women should not donate eggs and men should not donate sperm during the study treatment period and for at least 90 days after last IMP administration.
* All female participants must have a negative serum pregnancy test at Screening and Admission (Day -2).
Exclusion Crite…
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 78 post-dose