A First in Human Trial Evaluating THB335 in Healthy Participants

NCT06425861 | Completed Phase 1 FDA Drug

• 1 other identifier: THB335-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment-Related Adverse Events

  Part 1 Day 1 through Day 9 (end of study), and Part 2 Day 1 through Day 29 (end of study)

Secondary Outcomes (3)

• Maximum observed plasma concentration (Cmax)

  Part 1, and Part 2 on Day 1. Part 2 on Day 14

• Time to Cmax (Tmax)

  Part 1, and Part 2 on Day 1. Part 2 on Day 14

• Area under the plasma concentration-time curve (AUC)

  Part 1, and Part 2 on Day 1. Part 2 on Day 14

Study Arms (6)

THB335 single dose

EXPERIMENTAL

Single dose of THB335 fasted

Drug: THB335 single dose

THB335 fasted and fed

EXPERIMENTAL

Single dose of THB335 fasted and then fed

Drug: THB335 fasted/fed

THB335 multiple dose

EXPERIMENTAL

14 days of multiple ascending doses of THB335

Drug: THB335 multiple dose

Single dose placebo

PLACEBO COMPARATOR

Single dose of placebo capsule, fasted

Drug: Single dose placebo

Fasted and fed placebo

PLACEBO COMPARATOR

Single dose of placebo capsule fasted and then fed

Drug: Placebo fasted/fed

Multiple dose placebo

PLACEBO COMPARATOR

14 days of multiple doses of placebo capsule

Drug: Multiple dose placebo

Interventions

THB335 single dose DRUG

Single dose as oral capsule

THB335 single dose

Single dose placebo DRUG

Single dose as oral capsule

Single dose placebo

THB335 fasted/fed DRUG

Single dose fasted and fed as oral capsule

THB335 fasted and fed

Placebo fasted/fed DRUG

Single dose fasted and fed as oral capsule

Fasted and fed placebo

THB335 multiple dose DRUG

Multiple ascending doses oral capsule

THB335 multiple dose

Multiple dose placebo DRUG

Multiple doses oral capsule

Multiple dose placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Harmonic Bio, Inc.: lead

Study Sites (1)

QPS Miami

Miami, Florida, 33143, United States

Location

Study Officials

• Principal Investigator

  QPS Holdings LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 22, 2024
• Study Start: May 2, 2024
• Primary Completion: December 18, 2024
• Study Completion: December 18, 2024
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)