A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBD09

ClinicalTrials.gov ID: NCT07094932

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ClinicalTrials.gov public records Last synced Nov 13, 2026, 1:58 PM EST

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Official title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Trial in Healthy Adult Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBD09 With an 84-day Period of Fixed Daily Dosing

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a randomized, double-blind, placebo-controlled, multiple dose trial of TBD09, administered to healthy adult participants to assess safety, tolerability, and pharmacokinetics up to 84 days of fixed daily dosing of TBD09. The trial will be conducted with two cohorts, with participants enrolled in parallel and randomized to receive either TBD09 or placebo.

Study identification

NCT ID: NCT07094932
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Gates Medical Research Institute; Other
Enrollment: 36 participants

Conditions and interventions

Conditions

Healthy Adult Participants

Interventions

TBD09 Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 19 Years to 55 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 3, 2025 (Actual)
Primary completion: Jan 11, 2026 (Actual)
Completion: Jan 11, 2026 (Actual)
Last update posted: Jan 22, 2026

2025 – 2026

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Celerion	Lincoln	Nebraska	68502	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07094932, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jan 22, 2026 · Synced Nov 13, 2026