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

Trial Summary

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 the drug THB335 a promising treatment for healthy people?

The information provided does not directly address the effectiveness or promise of the drug THB335 for healthy people. The articles focus on topics like vitamin D, obesity, cardiovascular health, and gut microbiota, but do not mention THB335 or its potential benefits. ^{1 2 3 4 5}

What is the purpose of this trial?

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).

Research Team

Principal Investigator

Principal Investigator

QPS Holdings LLC

Eligibility Criteria

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.

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

I am in good health with no significant medical issues.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Vitamin D in overweight/obese women and its relationship with dietetic and anthropometric variables. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular health risks related to overweight. [2019]

3. England pubmed.ncbi.nlm.nih.gov

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

4. Germany pubmed.ncbi.nlm.nih.gov

The relation between 25-hydroxyvitamin D with peak bone mineral density and body composition in healthy young adults. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Pathophysiological role of host microbiota in the development of obesity. [2022]