About Clinical Research
Study #53823 – Study is Full

Multiple blood draws are required throughout the duration of this clinical research study

Have received an investigational product or device within 30 days prior to the first study drug administration.

Females of childbearing potential must agree to use highly effective contraceptive methods and avoid egg donation during the study treatment and for at least 184 days after the last dose of RLY-2608. Highly effective contraceptive methods include:
• Double barrier (condom, diaphragm or cervical cap with spermicidal foam, gel or cream) plus one of the following hormonal
methods, used consecutively for at least 3 months prior to first dose of study drug:
o Combined (estrogen and progestogen containing) oral, intravaginal or transdermal hormonal contraception associated with
the inhibition of ovulation
o Progestogen-only oral, injectable or implantable hormonal contraception associated with the inhibition of ovulation
o Intrauterine device
o Intrauterine hormone-releasing system (IUS)
• Vasectomized partner, if the vasectomized partner has received medical assessment of the surgical success
• Sexual abstinence, defined as refraining from heterosexual intercourse

A female is considered to be of child-bearing potential unless she:
• has had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy;
• has been amenorrhoeic for ≥ 12 months (including no irregular menses or spotting) in the absence of any medication which
induces a menopausal state and has documented ovarian insufficiency by follicle-stimulating hormone levels within the
institutional laboratory postmenopausal range.

Men of reproductive potential agree to use highly effective contraceptive methods and to avoid sperm donation during the study treatment and for 94 days after the last dose. A man is considered to be of child-producing potential unless he has had a bilateral vasectomy with documented aspermia, or a bilateral orchiectomy.
• Double barrier (condom, diaphragm or cervical cap with spermicidal foam, gel or cream) plus one of the following hormonal
methods, used consecutively for at least 3 months prior to first dose of study drug:
• Female partner on combined (estrogen and progestogen containing) oral, intravaginal or transdermal hormonal contraception
associated with the inhibition of ovulation
• Female partner on progestogen-only oral, injectable or implantable hormonal contraception associated with the inhibition of
ovulation
• Female partner with Intrauterine device
• Female partner with Intrauterine hormone-releasing system (IUS)
• Female partner not of child-bearing (defined in Inclusion #4)
• Sexual abstinence, defined as refraining from heterosexual intercourse