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NCT07182656
Safety, Tolerability, and PK/PD of CIGB-814 in Chinese Health Participants
Phase 1 trial testing CIGB-814 (single-dose group) in Rheumatoid Arthritis (RA) in 70 participants. Currently enrolling.
30 April 2026
Quick facts
| Lead sponsor | Yi Fang |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 70 |
| Start date | 18 August 2025 |
| Primary completion | 30 April 2026 |
| Estimated completion | 30 April 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- CIGB-814 (single-dose group) — full drug profile →
- CIGB-814 placebo (single-dose group)
- CIGB-814 (multiple-dose group) — full drug profile →
- CIGB-814 placebo (multiple-dose group)
Conditions studied
- Rheumatoid Arthritis (RA) — all drugs for Rheumatoid Arthritis (RA) →
Sponsor
Yi Fang — full company profile →
Who can join
Adults 18 to 45, any sex, with Rheumatoid Arthritis (RA). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of CIGB-814 for injection after single and multiple administrations in healthy participants. Secondary objectives include the assessment of preliminary pharmacodynamics (PD) and immunogenicity. Exploratory objectives are to investigate changes in immune cell subsets and signaling pathways following multiple administrations of CIGB-814.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07182656
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Yi Fang trials
Trials by the same sponsor.
- NCT05864261 — Pharmacokinetics Comparison Study of JT1801 and NESP® After Single Dose Administration in Chinese Health Male Volunteers · Phase 4 · 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 NCT07182656 (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 Yi Fang
- Last refreshed: 19 September 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/NCT07182656.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing