| Eligibility |
Inclusion Criteria:
1. Age 18 to 60 years, inclusive, at the time of Screening.
2. A female study subject must meet one of the following criteria: If of childbearing
potential - agrees to use one of the accepted contraceptive regimens from at least 30
days prior to the first administration of the study intervention, during the study,
and for at least 30 days after the last dose of the study intervention.
a. An acceptable method of contraception includes one of the following: i. Abstinence
from heterosexual intercourse ii. Hormonal contraceptives (birth control pills,
injectable/implant/insertable hormonal birth control products, transdermal patch) iii.
Intrauterine device (with or without hormones) -OR- b. Agrees to use a double barrier
method (eg, condom and spermicide) during the study and for at least 30 days after the
last dose of the study intervention Female subjects who are not of childbearing
potential are exempt from contraceptive requirements. To be considered of
nonchildbearing potential female subjects must meet the following requirements: Must
be surgically sterile (documented hysterectomy, tubal ligation, or bilateral
salpingo-oophorectomy at least 3 months prior to Day 1) or postmenopausal (defined as
12 months from the time of last spontaneous menses). If necessary, a
follicle-stimulating hormone (FSH) level > 35 IU/L at Screening will be considered
confirmatory in the absence of a clear postmenopausal history.
3. A male study subject who engages in sexual activity that has the risk of pregnancy
must agree to use a double barrier method (eg, condom and spermicide) and agree to not
donate sperm during the study and for at least 90 days after the last dose of the
study intervention.
4. Medically healthy on the basis of medical history, physical examination, and clinical
laboratory testing in the opinion of the Investigator or designee.
5. Nonsmokers and nonusers of nicotine-containing products, including e-cigarettes, for
at least 6 continuous months before the first dose of study intervention and for the
duration of the study, to be confirmed by cotinine testing at Screening.
6. Negative drug/alcohol testing at Screening and Check-in (Day -1).
7. Vital signs (after semirecumbent for at least 5 minutes) that are within the following
ranges at Screening and Check-in (Day -1):
1. Systolic blood pressure (BP), 90 to 140 mmHg, inclusive
2. Diastolic BP, 50 to 90 mmHg, inclusive
3. Heart rate (HR), > 45 to = 100 bpm
8. Weight = 90 kg and body mass index (BMI) = 18 and = 30 kg/m2 at Screening.
9. Normal renal function, defined as estimated creatinine clearance (CrCl) > 90 mL/min
(calculated using the Modification of Diet in Renal Disease [MDRD] formula) at
Screening; an Investigator can determine based on clinical judgment whether a lower
clearance rate can be accepted based on the muscle composition of the subject.
10. Willing and able to provide voluntary, written informed consent to participate in the
study.
11. Able to communicate well with the Investigator and/or study site personnel and to
comply with the requirements of the entire study.
Exclusion Criteria:
1. Use of any prescription or over-the-counter (OTC) medications, herbal products (eg, St
John's Wort, milk thistle), or supplements/vitamins within 14 days before dosing with
study intervention and for the duration of the study, with the exception of those
approved by the Investigator and Sponsor (eg, oral contraceptives, hormone replacement
therapy).
2. Receipt of any investigational agent or treatment within 30 days or 5 half-lives,
whichever is longer, prior to Screening.
3. Receipt of any protein- or antibody-based therapeutic agents (eg, growth hormones or
monoclonal antibodies) within 3 months before dosing with study intervention.
Note: Influenza and COVID-19 vaccine will be allowed if all doses in the regimen have
been administered more than 21 days before dosing with study intervention.
4. History of any major surgery within 6 months before dosing with study intervention.
5. History of hepatic disease, or current clinically significant liver function test
results, defined as alanine transaminase (ALT), aspartate transaminase (AST), total
bilirubin and fractionated bilirubin, and alkaline phosphatase (AP) > 1.5 × upper
limit of normal (ULN) at Screening.
Note: Isolated bilirubin > 1.5 × ULN is acceptable if bilirubin is fractionated and
direct bilirubin is < 35%.
6. History of any clinically relevant or chronic psychiatric, renal, hepatic, pancreatic,
cardiovascular, neurological, hematological, or gastrointestinal abnormality (eg,
inflammatory bowel disease).
7. History of severe allergic/anaphylactic reaction.
8. Diagnosis or positive Screening test for antinuclear antibodies (ANA),
anti-double-stranded deoxyribonucleic acid (DNA) antibodies (anti-dsDNA),
anti-ribonucleoprotein antibodies (anti-RNP), anti-Sjögren's syndrome type A
antibodies (anti-Ro/SSA), anti-Sjögren's syndrome type B antibodies (anti-La/SSB),
anti-Smith antibodies (anti-SM), and anti-phospholipid antibodies.
9. Subjects with a history of autoimmune disease, glomerulonephritis, or vasculitis.
10. Known history of allergy to any component of study intervention including polyethylene
glycol (PEG).
11. History of any active infection within 14 days dosing with study intervention, if
deemed clinically significant by the Investigator and Sponsor.
12. Any acute illness within 30 days before dosing with study intervention.
13. History of warfarin use or International Normalized Ratio (INR) = 1.5.
14. Has a history (within 2 years before the first dose of study intervention) of moderate
or severe use disorder for any substance other than caffeine (based on the Diagnostic
and Statistical Manual of Mental Disorders, 5th Edition [DSM-5] criteria).
15. Diagnosis of or positive Screening result for hepatitis B surface antigen (HBsAg),
hepatitis C virus antibody (HCVAb), or human immunodeficiency virus (HIV)-1 or HIV-2.
16. Positive COVID-19 test or any prior COVID-19 diagnosis.
17. Existence of any surgical or medical condition that, in the judgment of the
Investigator, might interfere with the absorption, distribution, metabolism, or
excretion of RLS-0071.
18. Presence of clinically significant electrocardiogram (ECG) finding (confirmed upon
repeat testing) that, in the opinion of the Investigator and/or Sponsor, may interfere
with any aspect of study conduct or interpretation of results, as follows:
1. QTcF > 450 msec for males and > 470 msec for females or low, or flat T-waves
making measurement of the interval unreliable at Screening or check-in (Day -1)
2. Other ECG abnormalities considered clinically relevant in the judgment of the
Investigator
19. Concurrent conditions that could interfere with safety and/or tolerability
measurements, as determined by the Investigator or a designee.
20. Pregnant and/or lactating.
21. Blood donation (excluding plasma donation) of approximately 500 mL within 56 days
prior to Screening.
22. Plasma donation within 7 days of Screening.
23. Inability to tolerate IV administration.
24. Poor venous access, as determined by the Investigator or a designee.
25. Unable or unwilling to cooperate with the site staff for any reason.
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