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

Inclusion Criteria12

If male, agrees to use adequate methods of contraception for at least 90 days after dosing, or if female, is of non-childbearing potential by meeting EITHER of the following criteria: a) Is in a postmenopausal state, defined as no menses for 12 months without an alternative medical cause and follicle-stimulating hormone level consistent with postmenopause (greater than or equal to 23 U/L) b) Has a documented hysterectomy, bilateral oophorectomy, or salpingectomy
Is judged to be in good health based upon medical history, physical examination, vital signs, ECGs, and routine laboratory tests.
Has a BMI (body mass index) between 18 and 32 kg/m², inclusive, and body weight of at least 55 kg at screening.
Meets BOTH of the following criteria for the screening ECG and baseline ECGs:
a) Has ECG parameters within the normal range, defined as meeting ALL of the following:
i. Heart rate (HR): greater than or equal to 45 beats per minute (bpm) to less than 100 bpm
ii. PR interval: greater than or equal to 120 to less than or equal to 220 milliseconds (ms)
iii. QRSD: less than 120 ms
iv. QT: less than 500 ms
v. QTc (HR-corrected QT interval): greater than or equal to 450 ms
b) Has no clinically significant ECG abnormality as assessed by the principal investigator or delegate.
Agrees to refrain from consumption of alcohol for at least 48 hours before the start of the inpatient period and each scheduled visit at the clinical unit.

Exclusion Criteria11

Participants are excluded from the study if any of the following criteria apply:
Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of significant psychiatric disorders as determined by the principal investigator or delegate.
Has any clinically significant physical examination abnormalities observed during the screening visit or would not be a good candidate for participation in the study in the opinion of the principal investigator or delegate.
Has clinically significant abnormal hematology, clinical chemistry, or urine analysis at screening or Day minus 1.
Was hospitalized for any reason within thirty days before the screening visit.
Has any history of clinically significant renal, neurologic, gastrointestinal, hepatic, or respiratory disease. Note that subjects with fully resolved childhood asthma with no recurrence in adulthood, subjects with a history of a previous uncomplicated cholecystectomy who have fully recovered without any consequence, and subjects with a history of Gilbert’s syndrome may be enrolled.
Has a more than ten pack year smoking history (for example, one pack per day times ten years) or currently smokes more than twenty cigarettes per week.
Has a history of anaphylaxis or other significant allergy in the opinion of the principal investigator or delegate.
Has a history of clinically significant cardiovascular disease including arrhythmias, conduction abnormalities, or clinically significant abnormal vital signs.
Had a recent (within the previous two months) bacterial, protozoal, viral, or parasite infection that required systemic treatment (antibiotics, antivirals, and so on). Topical treatments are permitted.
Has a history of tuberculosis or systemic fungal diseases.

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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)