COMPLETED

A First in Human Trial Evaluating THB335 in Healthy Participants

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is a double blind, randomized, placebo-controlled, Phase 1 study in three parts: single ascending doses and food effect (Part 1), multiple ascending doses (Part 2) and Relative Bioavailability of Two Formulations (Part 3).

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Food Effect of THB335 in Healthy Participants

Quick Facts

Study Start:2024-05-02
Study Completion:2024-12-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06425861

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * In good health, determined by no clinically significant findings from medical history, 12 lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations
  2. * Males or females, of any race, between 18 and 65 years of age, inclusive.
  3. * Participants must understand the nature of the study and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study related procedures
  4. * Body weight of ≥ 50.0 kg for men and ≥ 45.0 kg for women and Body Mass Index (BMI) of 17.5-32.0 kg/m2 (inclusive) at Screening
  1. * Significant history or clinical manifestation of cancer or any metabolic, allergic, dermatological, hepatic, biliary, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
  2. * Vaccinated within 14 days prior to Day -1 or intention to receive vaccination during the study
  3. * A positive urine drug screen/alcohol breath test
  4. * The participant currently smokes, vapes, or uses nicotine-containing products.

Contacts and Locations

Principal Investigator

Principal Investigator
PRINCIPAL_INVESTIGATOR
QPS Holdings LLC

Study Locations (Sites)

QPS Miami
Miami, Florida, 33143
United States

Collaborators and Investigators

Sponsor: Third Harmonic Bio, Inc.

  • Principal Investigator, PRINCIPAL_INVESTIGATOR, QPS Holdings LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-02
Study Completion Date2024-12-18

Study Record Updates

Study Start Date2024-05-02
Study Completion Date2024-12-18

Terms related to this study

Additional Relevant MeSH Terms

  • Healthy