THB335 for Healthy Subjects

Overseen By Third Harmonic Bio

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Third Harmonic Bio, Inc.

Disqualifiers: Cancer, Metabolic, Psychiatric, others

Compensation: Varies

Number of Visits: 4

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called THB335 to observe its effects in healthy adults. It includes different groups: some receive a single dose, others multiple doses, with some taking the treatment with food and others without. The trial also uses placebos (inactive substances) for comparison to better understand the effects. Individuals in good health, without significant medical conditions, and who do not use nicotine products may be suitable for this study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, since the study is for healthy subjects, it's likely that participants should not be on any regular medications.

Is there any evidence suggesting that THB335 is likely to be safe for humans?

Research has shown that THB335 is generally safe and well-tolerated. In earlier studies, most side effects were mild or moderate, with no serious adverse reactions reported. One study found a moderate decrease in neutrophils, a type of white blood cell, though this was uncommon. Some participants experienced mild increases in liver enzymes, but these were unrelated to the treatment. Overall, based on current data, THB335 appears safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about THB335 because it offers a potentially new approach to treatment with its unique delivery and dosing options. Unlike current treatments that may require consistent dosing, THB335 is being tested in both single and multiple dose formats, as well as in different dietary conditions (fasted vs. fed), which might provide flexibility in how the medication can be administered. This could make it more adaptable to individual patient needs and lifestyles. Additionally, the focus on multiple ascending doses over 14 days suggests a possibility for sustained efficacy, potentially improving long-term outcomes compared to existing options.

What evidence suggests that THB335 could be effective for healthy subjects?

Research has shown that THB335, a type of protein blocker, has a promising safety record in early trials with healthy individuals. Initial findings suggest that a single dose of THB335 is well-tolerated, causing no significant side effects at this stage. In this trial, participants may receive a single dose of THB335, either fasted or fasted and then fed, or multiple doses over two weeks. The body's processing of the drug supports the possibility of once-daily dosing. In trials where participants took multiple doses over two weeks, most tolerated the treatment well, with only a few experiencing minor, temporary issues. While these results are encouraging, it's important to remember that the research remains in the early stages and focuses mainly on safety, not yet on efficacy for a specific condition. ^{6 7 8 9 10}

Who Is on the Research Team?

Principal Investigator

Principal Investigator

QPS Holdings LLC

Are You a Good Fit for This Trial?

This trial is for healthy individuals who want to participate in a study testing a new medication. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and have no conflicting medical conditions.

Inclusion Criteria

I weigh at least 50 kg if male, 45 kg if female, and my BMI is between 17.5 and 32.

I am in good health with no significant medical issues.

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

Exclusion Criteria

A positive urine drug screen/alcohol breath test

I have been vaccinated or plan to be vaccinated soon.

I do not have a significant history of major health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose

Participants receive a single ascending dose of THB335 or placebo to assess safety and pharmacokinetics

1 week

1 visit (in-person)

Food Effect

Participants receive a single dose of THB335 fasted and then fed to evaluate the food effect

1 week

1 visit (in-person)

Multiple Ascending Dose

Participants receive multiple ascending doses of THB335 or placebo over 14 days to assess safety and pharmacokinetics

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• THB335

Trial Overview The trial is evaluating THB335, a new drug given as either a single dose or multiple doses under different conditions (fasted/fed). It's compared against a placebo in two parts: one to see the effects of food on the drug and another over repeated doses.

How Is the Trial Designed?

Group I: THB335 single dose Experimental Treatment 1 Intervention

Single dose of THB335 fasted

Group II: THB335 multiple dose Experimental Treatment 1 Intervention

14 days of multiple ascending doses of THB335

Group III: THB335 fasted and fed Experimental Treatment 1 Intervention

Single dose of THB335 fasted and then fed

Group IV: Single dose placebo Placebo Group 1 Intervention

Single dose of placebo capsule, fasted

Group V: Fasted and fed placebo Placebo Group 1 Intervention

Single dose of placebo capsule fasted and then fed

Group VI: Multiple dose placebo Placebo Group 1 Intervention

14 days of multiple doses of placebo capsule

Who Is Running the Clinical Trial?

Third Harmonic Bio, Inc.

Lead Sponsor

Trials

2

Recruited

60+

Published Research Related to This Trial

In a study of 66 overweight/obese Spanish women aged 20-35, those with higher vitamin D levels (≥90 nmol/l) had significantly lower body weight, BMI, and waist circumference compared to those with lower levels (<90 nmol/l).

The findings suggest that excess body fat is a major factor contributing to vitamin D deficiency in overweight/obese women, rather than inadequate dietary intake of vitamin D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitamin D in overweight/obese women and its relationship with dietetic and anthropometric variables. Rodríguez-Rodríguez, E., Navia, B., López-Sobaler, AM., et al.[2022]

Obesity is linked to various health risks, including cardiovascular diseases and type 2 diabetes, affecting approximately 1.7 billion people globally, particularly in developed countries.

Research suggests that gut microbiota may play a crucial role in obesity by influencing energy balance and metabolic processes, with prebiotics and probiotics showing potential in maintaining a healthy microbiota and controlling obesity-related factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathophysiological role of host microbiota in the development of obesity. Kobyliak, N., Virchenko, O., Falalyeyeva, T.[2022]

In a study of 464 healthy young adults, higher levels of 25 hydroxyvitamin D (25OHD) were linked to increased peak bone mineral density (BMD) in both women and men, indicating its importance for bone health.

The study found that in women, higher 25OHD levels were associated with lower body fat percentage, while in men, higher levels were linked to greater total body BMD and lean body mass, suggesting different roles of vitamin D in body composition between sexes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relation between 25-hydroxyvitamin D with peak bone mineral density and body composition in healthy young adults. Boot, AM., Krenning, EP., de Muinck Keizer-Schrama, SM.[2022]

Despite a decrease in the percentage of total fat and saturated fat intake, the overall prevalence of overweight individuals in the U.S. has increased, indicating a need for better energy balance management.

Overweight individuals show higher cardiovascular risk factors, such as high blood pressure and high cholesterol, highlighting the importance of addressing both weight and dietary habits in health care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular health risks related to overweight. Ernst, ND., Obarzanek, E., Clark, MB., et al.[2019]

In a cross-sectional study of healthy men and women in the U.S., waist circumference measurements were found to be normally distributed, indicating a wide range of values among this population.

The recommended waist circumference cutoffs of 102 cm for men and 88 cm for women align closely with the 95th percentile for healthy individuals, suggesting that few healthy people exceed these measurements, while lower action levels of 94 cm for men and 80 cm for women are more sensitive but less specific.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Waist circumference of healthy men and women in the United States. Flegal, KM.[2009]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06425861/a-first-in-human-trial-evaluating-thb335-in-healthy-participants

A First in Human Trial Evaluating THB335 in Healthy ... The study will evaluate the safety, pharmacokinetics, pharmacodynamics, and food effect profile of THB335 administered orally in healthy participants.

2. ctv.veeva.com ctv.veeva.com/study/a-first-in-human-trial-evaluating-thb335-in-healthy-participants

A First in Human Trial Evaluating THB335 in Healthy ... The study will evaluate the safety, pharmacokinetics, pharmacodynamics, and food effect profile of THB335 administered orally in healthy ...

3. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-4-2024-494f7

THB335 for Healthy Subjects This trial is for healthy individuals who want to participate in a study testing a new medication. Specific eligibility criteria are not provided, but typically ...

4. trial.medpath.com trial.medpath.com/organization/b0f2eb263931dd50/third-harmonic-bio

Third Harmonic Bio | MedPath Third Harmonic Bio's Phase 1 trial of THB335, a selective KIT inhibitor, demonstrated favorable safety profile and pharmacokinetics supporting once-daily dosing ...

5. sigma.larvol.com sigma.larvol.com/facility.php?FacilityId=3354607

St. George Hospital, Dept. Renal Medicine Trials ... THB335 in Healthy Participants ... 1. 56. US. THB335 single dose, Single dose placebo, THB335 fasted/fed, Placebo fasted/fed, THB335 multiple dose, Multiple dose ...

6. jacionline.org jacionline.org/article/S0091-6749(24)01965-1/fulltext

First-in-human study of THB335, an oral small molecule ... All part 1 AEs were mild or moderate in grade, with no SAEs or notable safety trends reported in any cohort. THB335 systemic exposure was linear up to doses ...

7. firstwordpharma.com firstwordpharma.com/story/5972392

Third Harmonic Bio Announces Stockholder Approval of ... All adverse events were mild, with the exception of one moderate adverse event of neutrophil reduction. There were no adverse events due to ...

8. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/third-harmonic-bio-announces-phase-1-thb335-clinical-results-update/

Third Harmonic Bio Announces Phase 1 THB335 ... The drug was generally safe and well-tolerated, with isolated transaminase elevations deemed unrelated to THB335. Other adverse events, such as ...

9. biospace.com biospace.com/press-releases/third-harmonic-bio-announces-phase-1-clinical-results-for-thb335-and-provides-corporate-strategic-update

Third Harmonic Bio Announces Phase 1 Clinical Results ... THB335 was generally safe and well tolerated in the SAD cohorts. ... adverse events observed in this study. The full Phase 1 clinical ...

10. synapse.patsnap.com synapse.patsnap.com/drug/5994bb27ec6c4d119d11981ea3f9c572

THB-335 - Drug Targets, Indications, Patents There were no adverse events due to hemoglobin reduction, nor any other clinically significant laboratory value changes reported in the cohort. One subject ...