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NCT06673927
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of YZJ-1139 in Healthy Participants
Phase 1 trial testing YZJ-1139 in Insomnia in 104 participants. Completed in 8 March 2019.
21 November 2018
Quick facts
| Lead sponsor | Shanghai Haiyan Pharmaceutical Technology Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 104 |
| Start date | 1 December 2017 |
| Primary completion | 21 November 2018 |
| Estimated completion | 8 March 2019 |
| Sites | 1 location across China |
Drugs / interventions tested
Conditions studied
- Insomnia — all drugs for Insomnia →
Sponsor
Shanghai Haiyan Pharmaceutical Technology Co., Ltd. — full company profile →
Who can join
Adults 18 to 45, any sex, with Insomnia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Primary Objective： 1. To evaluate the tolerability, safety of single and multiple doses of YZJ-1139 in healthy participants 2. To evaluate the pharmacokinetic of single and multiple doses of YZJ-1139 in healthy participants Secondary objectives: To explore the safe tolerated dose of YZJ-1139, provide data support for the design of phase II dosing regimen
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Pharmacokinetics, Pharmacodynamic, Safety and Tolerability of Fazamorexant, a Novel Dual Orexin Receptor Antagonist: Report of the First-in-Human Study.
Ni J, Jin L, Zhao D, Zhang W, et al · · 2025 · cited 2× · PMID 40552089 · DOI 10.2147/dddt.s501111
Verify or expand the search:
- PubMed search for NCT06673927
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of YZJ-1139
Trials testing the same drug.
- NCT06671444 — Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Severe Renal Impairment and Normal Renal Impairment · Phase 1 · active not recruiting
- NCT06671509 — Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Mild, Moderate and Normal Hepatic Impairment · Phase 1 · completed
- NCT06685341 — PK/PD Study of YZJ-1139 · Phase 1 · completed
Other recruiting trials for Insomnia
Currently open trials in the same condition.
- NCT07384429 — Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease · Phase 4 · recruiting
- NCT07270406 — Healthy Behaviors for Insomnia Prevention in People With HIV and Ongoing Pain · NA · recruiting
- NCT07071324 — CF Wellness Program · NA · recruiting
- NCT07417813 — A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders · recruiting
- NCT06348082 — Project Women's Insomnia Sleep Health Equity Study (WISHES) · NA · recruiting
Other Shanghai Haiyan Pharmaceutical Technology Co., Ltd. trials
Trials by the same sponsor.
- NCT06671444 — Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Severe Renal Impairment and Normal Renal Impairment · Phase 1 · active not recruiting
- NCT06671509 — Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Mild, Moderate and Normal Hepatic Impairment · Phase 1 · completed
- NCT06681493 — A Phase 1 Study of YZJ-4729 Tartrate Injection in Healthy Chinese Subjects · Phase 1 · completed
- NCT06680505 — Safety and Efficacy Study of YZJ-1139 in Primary Chronic Insomnia Disorder · Phase 2 · completed
- NCT06685341 — PK/PD Study of YZJ-1139 · Phase 1 · completed
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 NCT06673927 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
- Last refreshed: 10 February 2025
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/NCT06673927.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing