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

Morphic Holdings, Inc, a wholly owned subsidiary of Eli Lilly and Company

Status and phase

Enrolling

Phase 1

Conditions

Healthy

Treatments

Drug: LY4292009

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06977880

Morf-440-101 (Other Identifier)

J6O-MC-UMAA (Other Identifier)

27728

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 11 patient groups, including a placebo group

Cohort A1

Experimental group

Description: