A First in Human Trial Evaluating THB335 in Healthy Participants

Description

This study is a double blind, randomized, placebo-controlled, Phase 1 study in two parts: single ascending doses and food effect (Part 1) and multiple ascending doses (Part 2).

Conditions

Healthy

Talk to us

Study Overview

On this page

Study Details

Study overview

This study is a double blind, randomized, placebo-controlled, Phase 1 study in two parts: single ascending doses and food effect (Part 1) and multiple ascending doses (Part 2).

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

A First in Human Trial Evaluating THB335 in Healthy Participants

Condition
Healthy
Intervention / Treatment

-

Contacts and Locations

Miami

QPS Miami, Miami, Florida, United States, 33143

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * In good health, determined by no clinically significant findings from medical history, 12 lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations
  • * Males or females, of any race, between 18 and 65 years of age, inclusive.
  • * 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
  • * 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
  • * 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
  • * Vaccinated within 14 days prior to Day -1 or intention to receive vaccination during the study
  • * A positive urine drug screen/alcohol breath test
  • * The participant currently smokes, vapes, or uses nicotine-containing products.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Third Harmonic Bio, Inc.,

Principal Investigator, PRINCIPAL_INVESTIGATOR, QPS Holdings LLC

Study Record Dates

2025-03-15