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Monoclonal Antibodies

THB335 for Healthy Subjects

Phase 1
Recruiting
Led By Principal Investigator
Research Sponsored by Third Harmonic Bio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
In good health, determined by no clinically significant findings from medical history, 12 lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is divided into two parts - Part 1 involves testing single doses and food effects, while Part 2 involves testing multiple doses. The study is double-blind and randomized, with a placebo control

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this is an early-stage trial for THB335 in healthy people, specific side effects aren't listed. However, common side effects in such trials can include nausea, headache, dizziness, or reactions at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I weigh at least 50 kg if male, 45 kg if female, and my BMI is between 17.5 and 32.
Select...
I am in good health with no significant medical issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: THB335 single doseExperimental Treatment1 Intervention
Single dose of THB335 fasted
Group II: THB335 multiple doseExperimental Treatment1 Intervention
14 days of multiple ascending doses of THB335
Group III: THB335 fasted and fedExperimental Treatment1 Intervention
Single dose of THB335 fasted and then fed
Group IV: Single dose placeboPlacebo Group1 Intervention
Single dose of placebo capsule, fasted
Group V: Fasted and fed placeboPlacebo Group1 Intervention
Single dose of placebo capsule fasted and then fed
Group VI: Multiple dose placeboPlacebo Group1 Intervention
14 days of multiple doses of placebo capsule

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Third Harmonic Bio, Inc.Lead Sponsor
1 Previous Clinical Trials
5 Total Patients Enrolled
Principal InvestigatorPrincipal InvestigatorQPS Holdings LLC
34 Previous Clinical Trials
4,096 Total Patients Enrolled
~34 spots leftby Mar 2025
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