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Purpose

The primary purpose of this study is to assess the efficacy, safety, and tolerability of KN3835 compared to placebo in the treatment of flexible/semi-flexible HMT.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Has no significant medical history or examination findings related to the foot to be treated, which in the investigator's opinion, would make the participant unsuitable for study intervention administration or study required evaluations. - If female, be of non-childbearing potential or, if of childbearing potential, be non-pregnant, non-lactating and agree to use effective contraception when with a male partner for the duration of the study and for 28 days after treatment. - Be willing and able to comply with all protocol required visits and assessments.

Exclusion Criteria

  • Has any musculoskeletal, neurosensory, other neurological or related disorder that affects the participant's use of his/her feet and/or would impair his/her completion of study assessments as determined by the investigator either due to the disorder or due to pain. - Has any significant medical condition(s), which in the investigator's opinion would make the participant unsuitable for enrollment in the study. - Has previously participated in clinical studies of KN3835 for plantar fasciitis, plantar fibromatosis, or HMT. Note: Other inclusion/exclusion criteria may apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
KN3835
  • Biological: KN3835
    Participants will receive KN3835.
    Other names:
    • EN3835
Placebo Comparator
Placebo
  • Other: Placebo
    Participants will receive placebo matching to KN3835.

Recruiting Locations

Keenova Site-009
Corona, California 92882

Keenova Site-008
Tarzana, California 91356

Keenova Site-004
Pinellas Park, Florida 33782

Keenova Site-007
Sweetwater, Florida 33172

Keenova Site-003
Bedford, Texas 76021

Keenova Site-002
McAllen, Texas 78501

Keenova Site-006
Salt Lake City, Utah 84107

More Details

Status
Recruiting
Sponsor
Endo USA Inc., a Keenova Therapeutics Company

Study Contact

Clinical Operations
800-462-3636
clinicaltrials@endo.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.