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

NCT06241742 | Completed Phase 2 FDA Drug

• 1 other identifier: HT-6184-PIR-001
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pain

Keywords

third molar extraction; inflammation; biomarkers

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Area under the categorical pain intensity-by-time curve (AUCs)

  Up to 8 hours after surgery

Study Arms (2)

HT-6184 Treatment Arm

ACTIVE COMPARATOR

Drug: HT-6184

HT-6184 Placebo

PLACEBO COMPARATOR

Drug: HT-6184 Placebo

Interventions

HT-6184 DRUG

Single, oral dose of HT-6184

HT-6184 Treatment Arm

HT-6184 Placebo DRUG

Single, oral dose of placebo

HT-6184 Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Halia Therapeutics, Inc.: lead

Study Sites (1)

CenExel JBR

Murray, Utah, 84107, United States

Location

MeSH Terms

Conditions

Pain; Inflammation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Halia Study Director

  Halia Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 5, 2024
• Study Start: February 12, 2024
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)