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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: Recruiting Phase 1 study of Acne, sponsored by Sagimet Biosciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What NCT06989840 shows while recruiting
NCT06989840 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 138-participant average among 26 other Acne trials with a reported enrollment target.
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Acne
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06989840's enrollment target sits among peer trials
128 7th of 26 higher than 19 of 26 other Acne trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acne trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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