Evaluating Ability of HT-6184 to Reduce Inflammation and Pain After Third Molar Extraction

Last updated: March 27, 2025
Sponsor: Halia Therapeutics, Inc.
Overall Status: Completed

Phase

2

Condition

Inflammation

Pain

Treatment

HT-6184

HT-6184 Placebo

Clinical Study ID

NCT06241742
HT-6184-PIR-001
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The goal of this clinical trial is to test the ability of HT-6184 to decrease inflammation and pain in patients after third molar removal.

The main question it aims to answer are:

  • Does HT-6184 decrease inflammation in patients after third molar removal?

  • Does HT-6184 decrease pain in patients after third molar removal?

Participants will be asked to do the following during the clinical trial:

  • Take a single oral dose of HT-6184 or placebo

  • Allow a oral surgeon remove their third molar teeth

  • Blood draws on 5 occurrences

  • Rate their pain intensity

  • Attend two follow-up appointments on day 1 and day 2 after third molar removal

  • Participate in one follow-up phone call 5-7 days after third molar removal

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The candidate is 18 years of age or older, capable of understanding and providingwritten informed consent to participate and willing to comply with study proceduresincluding providing a blood sample to be saved for potential pharmacokinetic and/orgenetic analysis.

  • The candidate, for any reason, requires surgical extraction of two or more thirdmolars of which at least one is partially or fully impacted in mandibular bone.

  • The candidate is postmenopausal, surgically sterile or agrees to use an effectiveand medically acceptable method of contraception for 1 week after his or her lastdose of study drug.

  • If female with child-bearing potential, the candidate must have a negative pregnancytest at screening and pre-surgery on the day of surgery.

Exclusion

Exclusion Criteria:

  • The candidate typically or on average consumes more than one alcoholic beverage perday.

  • The candidate is pregnant or nursing.

  • The candidate has received an investigational drug or used an experimental medicaldevice within 30 days prior to screening.

  • The candidate has donated 1 or more pints of blood within 8 weeks prior toscreening.

  • The candidate has any hypersensitivity to components of the HT-6184/placeboformulations or the protocol-specified analgesic rescue medication, aspirin ornonsteroidal anti-inflammatory drugs (NSAIDs).

  • The candidate has any contraindication to oral surgery or any serious or majormedical problems that, in the investigator's opinion, may compromise the safety orthe candidate or interfere with the interpretation of study results

  • The candidate has taken acetaminophen, NSAIDs (including aspirin) or othermedications for pain within 72 hours of the surgical procedure.

  • The candidate has any abnormal laboratory value or physical finding that, in theopinion of the investigator, may compromise the individual's safety, interfere withinterpretation of the study results, or be indicative of an underlying diseasestate.

Study Design

Total Participants: 81
Treatment Group(s): 2
Primary Treatment: HT-6184
Phase: 2
Study Start date:
February 12, 2024
Estimated Completion Date:
April 30, 2024

Connect with a study center

  • CenExel JBR

    Murray, Utah 84107
    United States

    Site Not Available

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