A Randomized, Placebo-Controlled, Double-blind, Multiple Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Following Intravenous Administration of SRK-001 in Healthy Participants.
- Conditions
- SLEsystemic lupus erythematosus10003816
- Registration Number
- NL-OMON52159
- Lead Sponsor
- Sarkana Pharma, Inc.
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1. Participant must be 18 to 65 years of age at the time of signing the
informed consent.
2. Participants who have clinical chemistry laboratory values within acceptable
range for the population, as per investigator judgment
3. Body mass index of 18 to 32 kg/m2, inclusive
4. Healthy male participants
a. Nonvasectomized male participants must agree to abstain from sexual
intercourse or use a condom as well as 1 additional highly effective
method of contraception (<1% failure rate) or effective method of contraception
with all sexual partners of
childbearing potential during the study and for 90 days following the last dose
of study intervention.
b. Must agree not to donate sperm from start of dosing until 90 days beyond the
last dose of study intervention.
c. No restrictions are required for a vasectomized male provided his vasectomy
has been performed and confirmed to be effective by a semen sample lacking
sperm at least 3 months or more prior to screening. A male who has been
vasectomized or <3 months prior to screening must follow the same restrictions
as a nonvasectomized male.
5. Healthy female participants of childbearing potential who have a fertile
male sexual partner must be willing and able to practice effective
contraception from screening to 90 days after the last dose of study
intervention. Sexually active participants must use a combination of 2 of
the following methods of contraception, including at least 1 so-called
'barrier' method:
a. hormonal contraceptives (oral, transdermal patches, vaginal, or injectable)
b. intrauterine device with or without hormones
c. condom, diaphragm, or cervical cap ('barrier' method)
d. sexual abstinence, and
e. vasectomized partner.
Contraceptive requirements do not apply for participants who are exclusively in
a same-sex relationship.
Further criteria apply, see protocol.
1. Have any concomitant disorder that, in the opinion of the investigator,
would preclude participation in the study.
2. For at least 30 days prior to randomization, participants must have no
symptoms and/or signs of confirmed or suspected infection (including
COVID-19) and must have completed any appropriate anti-infective treatment.
3. Have human immunodeficiency virus (HIV) infection.
4. Have a current infection with hepatitis B virus (HBV) (that is, positive for
hepatitis B surface antigen and/or polymerase chain reaction positive for HBV
DNA.
5. Have a current infection with hepatitis C virus (HCV) (that is, positive for
HCV RNA).
Further criteria apply, see protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>TEAEs and SAEs.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• AUC0-tau at steady state<br /><br>• Half-life (t1/2)<br /><br>• Concentrations at end of infusion (Cmax) and<br /><br>end of dosing interval (Ctrough)</p><br>