RecruitingPhase 1ACTRN12626000242325

A single ascending dose study of TX002100 in healthy participants

A double-blind, randomized, placebo-controlled, single ascending dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of TX002100 in healthy participants

Sponsor

Tectonic Operating Company. Inc.

Enrollment

48 participants

Start Date

Feb 24, 2026

Study Type

Interventional

Conditions

Hereditary hemorrhagic telangiectasia

Summary

This double-blind, placebo-controlled, first-in-human (FIH) study will assess the safety, tolerability, PK, and immunogenicity of TX002100. This study seeks to establish doses of TX002100 that are safe, well tolerated, and exhibit an appropriate PK profile to warrant further clinical investigation. Six cohorts of 8 participants each are planned. Participants will be randomized in a 3:1 ratio to receive a single dose of TX002100 or matching placebo. Planned evaluations will include approximately 48 healthy men or healthy women of non–childbearing potential

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 55 Yearss

Plain Language Summary

Simplified for easier understanding

TX002100 is a brand-new investigational medication being tested in humans for the very first time in this study. Before any new drug can be approved for patients, researchers must carefully test it in healthy volunteers to understand how the body absorbs, processes, and tolerates it. This type of study is called a 'first-in-human' trial, and it is designed with safety as the top priority. Participants will receive a single dose of either TX002100 or a placebo (an inactive substance), and will be closely monitored in a clinical unit for any side effects. Six different dose levels will be tested across separate groups of 8 participants each, with most participants receiving the real drug and a smaller number receiving the placebo. The study will build up the dose gradually to ensure safety at each level. You may be eligible if you are between 18 and 55 years old, are in good general health, have a healthy BMI (18-32 kg/m²), and have normal heart function on an ECG. Women must be postmenopausal or have had a surgical procedure that prevents pregnancy. Men must agree to use contraception for 90 days after the dose. People with significant medical history, heavy smoking history, or recent infections would not be eligible.

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Interventions

TX002100 is an Fc-fusion protein. Investigational product: TX002100 or Matching placebo. Approximately 48 participants will be enrolled in this study. Single dose of TX002100 or matching placebo, ran

TX002100 is an Fc-fusion protein. Investigational product: TX002100 or Matching placebo. Approximately 48 participants will be enrolled in this study. Single dose of TX002100 or matching placebo, randomized in a 3:1 ratio per cohort, via at least a 30-minute intravenous (IV) infusion or via subcutaneous (SC) injection. Doses administered: Single ascending doses of TX002100 as follows: Cohort A: 0.1 mg/kg IV; Cohort B: 0.3 mg/kg IV; Cohort C: 100 mg SC (may be concurrent with B); Cohort D: 1 mg/kg IV; Cohort E: 300 mg SC (may be concurrent with D); Cohort F: 600 mg SC. Additional cohorts or dose adjustments may be added based on safety and tolerability in this first-in-human study. How is the mode of administration decided: Each participant will receive a single dose of TX002100 or matching placebo, randomized in a 3:1 ratio per cohort, via at least a 30-minute intravenous (IV) infusion or via subcutaneous (SC) injection. In a sequential, dose-ascending manner, proposed doses to be administered are as follows: • Cohort A: 0.1 mg/kg IV of TX002100 or matching placebo • Cohort B: 0.3 mg/kg IV of TX002100 or matching placebo • Cohort C: 100 mg SC of TX002100 or matching placebo; Cohort C may be dosed concurrently with Cohort B • Cohort D: 1 mg/kg IV of TX002100 or matching placebo • Cohort E: 300 mg SC of TX002100 or matching placebo; Cohort E may be dosed concurrently with Cohort D • Cohort F: 600 mg SC of TX002100 or matching placebo As this is an FIH study, additional cohorts may be added or cohort doses may be decreased or repeated as required based upon safety and tolerability demonstrated during the trial. Strategies to monitor adherence: Not applicable, as this is a single-dose, inpatient Phase 1 study in a clinical unit where dosing occurs under direct supervision on Day 1 (with 24-hour post-dose observation)

Locations(1)

CMAX Clinical Research Pty Ltd - Adelaide

SA, Australia

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ACTRN12626000242325