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NCT06989840 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne
A Phase 1 study of Acne, sponsored by Sagimet Biosciences.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 128
- Enrollment target
- 2
- Study locations
NCT06989840 is a Phase 1 study of Acne that is actively recruiting participants, run by Sagimet Biosciences. The registered enrollment target is 128 participants, roughly in line with the 138-participant average among 26 other Acne trials with a reported enrollment target. The trial reports 2 study locations across 2 states.
The verdict
NCT06989840, a Phase 1 study of Acne, is actively recruiting participants, sponsored by Sagimet Biosciences.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 128 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a 4-part study. Part A will be a randomized, double-blind, placebo-controlled investigation of single ascending doses (SAD) to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) biomarkers of TVB-3567 administered orally in healthy participants. Part B will be a randomized, open-label, 2-way crossover investigation to assess the effect of food on a single dose TVB-3567 administered orally in healthy participants. Parts C and D will be randomized, double-blind, placebo-controlled investigations of multiple ascending doses (MAD) to assess the safety, tolerability, PK, and PD/biomarkers of TVB-3567 administered orally in healthy participants without and with moderate to severe acne, respectively.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TVB-3567
Study Locations (2)
Arizona
- Celerion, Inc. - Tempe
Victoria
- Nucleus Network - Melbourne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2025-06-03 |
| Est. Completion | 2026-06-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06989840
The ClinicalTrials.gov registry entry for NCT06989840 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 138-participant average among 26 other Acne trials with a reported enrollment target. The listed sponsor is Sagimet Biosciences, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Acne appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06989840 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Arizona, Victoria.
Frequently Asked Questions
What is clinical trial NCT06989840 about?
NCT06989840 is a clinical study titled "Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne". This is a 4-part study. Part A will be a randomized, double-blind, placebo-controlled investigation of single ascending doses (SAD) to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) biomarkers of TVB-3567 administered orally in healthy participants. Part B will be a...
What is the current status of trial NCT06989840?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 128 participants. The study started on 2025-06-03. Estimated completion is 2026-06-01.
What conditions does trial NCT06989840 study?
This clinical trial studies the following conditions: Acne.
What interventions are being tested in trial NCT06989840?
The interventions under investigation include: Placebo (DRUG), TVB-3567 (DRUG).
Who is sponsoring clinical trial NCT06989840?
This trial is sponsored by Sagimet Biosciences, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06989840 being conducted?
This trial has 2 study locations across Arizona, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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