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NCT05542303
A Safety, Tolerability and Pharmacokinetics Study of ZB001 in Healthy Subjects
Phase 1 trial testing ZB001 for injection in Healthy Volunteers in 24 participants. Completed in 4 April 2023.
4 April 2023
Quick facts
| Lead sponsor | Zenas BioPharma (USA), LLC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 16 October 2022 |
| Primary completion | 4 April 2023 |
| Estimated completion | 4 April 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- ZB001 for injection — full drug profile →
- ZB001 for injection — full drug profile →
- ZB001 for injection — full drug profile →
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
Sponsor
Zenas BioPharma (USA), LLC — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The investigational drug, ZB001 is a humanized IgG1κ monoclonal antibody (mAb) targeting human IGF-1R. This clinical trial will examine the safety, tolerability, and pharmacokinetics (PK) of single ascending doses of ZB001 in healthy Chinese subjects.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05542303
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ZB001 for injection
Trials testing the same drug.
- NCT05776121 — Study of ZB001 in Chinese Patients With Thyroid Eye Disease · Phase 1 · completed
Other recruiting trials for Healthy Volunteers
Currently open trials in the same condition.
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- NCT07499050 — A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity · Phase 1 · recruiting
- NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting
Other Zenas BioPharma (USA), LLC trials
Trials by the same sponsor.
- NCT05786573 — A Study of Obexelimab in Patients With Warm Autoimmune Hemolytic Anemia (SApHiAre) · Phase 3 · active not recruiting
- NCT05794516 — A Safety and Pharmacokinetics Study of ZB004 in Healthy Participants · Phase 1 · completed
- NCT05776121 — Study of ZB001 in Chinese Patients With Thyroid Eye Disease · Phase 1 · completed
- NCT05662241 — A Phase 3 Study of Obexelimab in Patients With IgG4-Related Disease · Phase 3 · active not recruiting
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 NCT05542303 (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 Zenas BioPharma (USA), LLC
- Last refreshed: 6 April 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/NCT05542303.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing