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NCT07373457
A Single-Center, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dosing, Dose-escalation, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, PK/PD, Food Effect of HW201877 in Healthy Volunteers.
Phase 1 trial testing HW201877 capsules in Healthy Participants in 104 participants. Currently enrolling.
1 March 2026
Quick facts
| Lead sponsor | Wuhan Humanwell Innovative Drug Research and Development Center Limited Company |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 104 |
| Start date | 26 June 2025 |
| Primary completion | 1 March 2026 |
| Estimated completion | 1 March 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- HW201877 capsules — full drug profile →
- Placebo
Conditions studied
- Healthy Participants — all drugs for Healthy Participants →
- IBD (Inflammatory Bowel Disease) — all drugs for IBD (Inflammatory Bowel Disease) →
Sponsor
Wuhan Humanwell Innovative Drug Research and Development Center Limited Company — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy Participants or IBD (Inflammatory Bowel Disease). Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The number and severity of treatment emergent adverse events (TEAEs)
Time frame: Day 1 to Day 5
To assess the safety and tolerability of single or multiple oral dose of HW201877 in healthy adult volunteers
Sponsor's own description
This is a Phase I, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and food effect (FE) of HW201877 in healthy subjects following (1) a single ascending dose (Part 1), which includes a single-dose, two-period crossover FE cohort; (2) a multiple ascending dose (Part 2).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07373457
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Wuhan Humanwell Innovative Drug Research and Development Center Limited Company trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07373457 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Wuhan Humanwell Innovative Drug Research and Development Center Limited Company
- Last refreshed: 19 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07373457.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing