A Phase 1, First-in-human Study of MORF-440 (LY4292009) in Healthy Participants

A Phase 1, First-in-human Study of MORF-440 in Healthy Participants, Including Single and Multiple Ascending Dose Cohorts

The purpose of this study is to evaluate the safety and tolerability of single ascending doses of MORF-440 administered to healthy participants single-ascending dose (SAD) and maximum ascending dose (MAD) substudy.

Inclusion Criteria:

• Body mass index (BMI) within 18.0 kg/m² to 30.0 kg/m², inclusive

• If male, meets one of the following:

  • can procreate and agree to use one of the accepted to use one of the accepted contraceptive regimens and not to donate sperm from the first study drug administration to at least 90 days after the last drug administration.
  • is unable to procreate; defined as surgically sterile (i.e., has undergone a vasectomy at least 180 days prior to the first study drug administration)

• if female, meets one of the following:

  • is of childbearing potential and agrees to use an acceptable contraceptive method.

  • is of non-childbearing potential, defined as either:

    • Surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or

  • is in a postmenopausal state:

    • At least 1 year without menses and without an alternative medical condition prior to the screening, and follicle stimulating hormone (FSH) levels ≥ 40 mIU/mL at screening or at least 1 year without menses and without an alternative medical condition prior to the screening, follicle stimulating hormone FSH levels < 40 milli-international units per milliliter (mIU/mL) and estradiol serum level ≤150 picomole/Liter (pmol/L) at screening

Exclusion Criteria:

• Female who is lactating or who is pregnant according to the pregnancy test at screening or prior to the first study drug administration, or planning to become pregnant during the study period up to 30 days after the last study drug administration
• Nicotine intake (e.g., smoking, nicotine patch, nicotine chewing gum, chewing tobacco, electronic cigarettes) within 1 month before screening and/or inability to refrain from nicotine from screening until the end of the study