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

A Phase-2 Study to Evaluate the Ability of HT-6184 to Attenuate Diagnostic Biomarkers of Post-procedure Acute Inflammation and Manage Pain Following Third Molar Extraction

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: HT-6184; Drug: HT-6184 Placebo

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84107
      • Cenexel JBR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• The candidate is 18 years of age or older, capable of understanding and providing written informed consent to participate and willing to comply with study procedures including providing a blood sample to be saved for potential pharmacokinetic and/or genetic analysis.
• The candidate, for any reason, requires surgical extraction of two or more third molars of which at least one is partially or fully impacted in mandibular bone.
• The candidate is postmenopausal, surgically sterile or agrees to use an effective and medically acceptable method of contraception for 1 week after his or her last dose of study drug.
• If female with child-bearing potential, the candidate must have a negative pregnancy test at screening and pre-surgery on the day of surgery.

Exclusion Criteria:

• The candidate typically or on average consumes more than one alcoholic beverage per day.
• The candidate is pregnant or nursing.
• The candidate has received an investigational drug or used an experimental medical device within 30 days prior to screening.
• The candidate has donated 1 or more pints of blood within 8 weeks prior to screening.
• The candidate has any hypersensitivity to components of the HT-6184/placebo formulations or the protocol-specified analgesic rescue medication, aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs).
• The candidate has any contraindication to oral surgery or any serious or major medical problems that, in the investigator's opinion, may compromise the safety or the candidate or interfere with the interpretation of study results
• The candidate has taken acetaminophen, NSAIDs (including aspirin) or other medications for pain within 72 hours of the surgical procedure.
• The candidate has any abnormal laboratory value or physical finding that, in the opinion of the investigator, may compromise the individual's safety, interfere with interpretation of the study results, or be indicative of an underlying disease state.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HT-6184 Treatment Arm	Drug: HT-6184; Single, oral dose of HT-6184
Placebo Comparator: HT-6184 Placebo	Drug: HT-6184 Placebo; Single, oral dose of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum C-reactive protein levels from pre-dose		Up to 54 hours post surgery
Incidence of adverse events	Severity of AEs will be judged according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	Up to 7 days post surgery
Incidence of serious adverse events	Severity of AEs will be judged according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	Up to 7 days post surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the categorical pain intensity-by-time curve (AUCs)	Up to 8 hours after surgery

Collaborators and Investigators

• Sponsor: Halia Therapeutics, Inc.
• Investigators: Study Director: Halia Study Director, Halia Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2024
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: January 15, 2024
• First Submitted That Met QC Criteria: January 26, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: biomarkers; inflammation; third molar extraction
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: HT-6184-PIR-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No