RecruitingPhase 1NCT06977880
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
Sponsor
Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
Enrollment
80 participants
Start Date
Feb 19, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria10
- 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 Criteria2
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGLY4292009
Administered orally
DRUGPlacebo
Administered orally.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06977880
Related Trials
Assessment of 11C-JMJ-129 for Imaging PDE4D in Brain and Whole Body of Healthy Volunteers
NCT068742051 location
Predicting Future Errors During Skill Performance
NCT067072071 location
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
NCT071696301 location
A Study Measuring Markers of Airway Inflammation in Breath Samples From People With Respiratory Diseases and Healthy Volunteers.
NCT074267181 location
Increasing Physical Activity Through Social Support and Stress Resilience
NCT068968251 location